Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219930

FEI Number

1219930

Entity Name

Covidien

City/State/Country

North Haven, CT, US

Establishment Address

60 Middletown Ave, North Haven, CT 06473, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102325

PMA Number

N/A

All Registered Proprietary Names

Auto Suture TriTis Non-Absorbable Force TriVerse Signia Circular Adapters, Tri-Staple 2 Circular Reloads AUTO SUTURE ENDO CATCH SPECIMAN BAG Purstring TRUCLEAR Operative Hysteroscope 5C- Refurbished/Service TRUCLEAR Operative Hysteroscope 5C TRUCLEAR Sheath 5C AccuMesh SPACEMAKER Purple Radial Reload Polypropylene Suture SILS Port Sofsilk SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOS Signia Loading Units Tri-staple 2 and Tri-staple 2.4 45mt and 60vt DG Surgilene Suture Signia Stapler Endo Lube Valleylab Suction Coagulator Valleylab Suction Coagulator, E3305 Valleylab Suction Coagulator, E3310 and E3310NSB TruClear Diagnostic Sheath Duo TruClear Operative Sheath Duo Versaport Absorbatack GIA Stapler with Tri-Staple Technology Step SD Suture Anchor DUET with Tri-Staple Endo GIA Reloads with Tri-Staple Technology Signia Small Diameter Reloads Tri-staple 2 Reloads Endo GIA Gray Articulating Reloads SILS Articulating Hand Instruments Laproclip Surgisleeve Wound Protector IO+ Port MaxTack Motorized Fixation Device TriTis 12 mm Non-Absorbable Endo GIA Pancreas Indication Laparascopic Electrodes w/Retractab Premium-SurgiClip III TruClear Elite Hysteroscope Mini (includes insert) TruClear Elite Hysteroscope Plus TruClear Elite Hysteroscope Mini TruClear Elite Hysteroscope Plus (includes insert) Elite hysteroscope plus - refurbished Elite hysteroscope mini- refurbished ReliaMax ENDO STITCH Radial Expandable LigaSure Exact Dissector Nano-coated, LF2019 GIA PREMIUM SURGIPORT DuraSeal Spine V-Loc SurgiGut TRUCLEAR ULTRA Plus Tissue Removal Device LigaSure¿ Impact LigaSure¿ V Surgiwip ROTICULATOR ENDO DISSECT - ENDO GRASP ENDO SLIDE V-LOC NA 8 TRUCLEAR Sheath 9 TRUCLEAR Obturator TRUCLEAR Operative Hysteroscope 4 Calibration Insert Tri-StapleTM 2 Circular Reloads Visiport Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 48 cm, SCDA48 Sonicision Reusable Generator, SCGAA Sonicision Battery Charger, CBCA Sonicision Reusable Battery Pack, SCBA Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 39 cm, SCDA39 Sonicision Reusable Battery Insertion Guide, SCBIGA Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 13 cm, SCDA13 Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 26 cm, SCDA26 Surgiport Gastrisail LigaSure Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944 LigaSure Maryland Jaw Open Sealer/Divider One-step Sealing, Nano-coated, LF1923 Hysteroscopic Outflow Tubes Set LIGATURE PASSING AND KNOT TYING ENDO CATCH CLIP IMPLANTABLE MULTAPPLIER Doubletime Trocar ENDO TA ENDO PEANUT Stratis ST Non-Absorbable Stratus Nonabsorbable ACL Fixation ENDO LUNG SILS PORT SurgiTie Micro-Needle Electrodes, E16XX Coated Electrodes Edge Needle Electrode, (6.5" (, 16.51 cm), E1452-6 Edge Insulated Blade Electrode, (4", (10.16 cm), E1455-4 and E1455-4NSB Edge Blade Electrode, (3 (, 7.62 cm), E1450G and E1450GNSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB Edge Insulated Blade Electrode, Safety Sleeve, (4" (, 10.16 cm), E1455B4 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350H Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465NSB Edge Insulated Blade Electrode, (6.5", (16.51 cm), E1455-6 and E1455-6NSB Edge Insulated Blade Electrode, Safety Sleeve (2.75", (7 cm), E1455NSB Edge Insulated Blade Electrode, Safety Sleeve, (2.75", (7 cm), E1455BNSB Valleylab Insulated Micro-Needle Electrode, 9 cm, E1654B Edge Button Switch Pencil Blade Electrode, Holster, E2450HGNSB Edge Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB Valleylab Straight Micro-Needle Electrode, 2 cm, E1650 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB Edge Coated Blade Extended Electrode, ( 4" , (10.16 cm), E1450-4 Edge Blade Electrode, (4", (10.16 cm), E1450-NSB Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465 Edge Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDB Valleylab Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652 Edge Hex-locking Blade Electrode, (2.5 (, 6.35 cm), E1450X and E1450XNSB Edge Insulated Blade Electrode, Safety Sleeve, (2.75" (, 7 cm), E1455B Edge Insulated Needle Electrode, 6.5" (16.51 cm), E1465-6 Edge Insulated Blade Electrode, Safety Sleeve, (4", (10.16 cm), E1455B-4NSB Edge Insulated Needle Electrode, Safety Sleeve, (4", (10.16 cm), E1465B-4 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB Edge Needle Electrode, (2.8", (7.2 cm), E1452NSB Edge Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB Edge Insulated Blade Electrode, (2.75", (7 cm), E1455 Valleylab Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653 Edge Button Switch Pencil Blade Electrode, Holster, E2450H Edge Needle Electrode, (2.8" (, 7.2 cm), E1452 Edge Button Switch Pencil Blade Electrode, Holster, E2450HNSB Edge Pencil Blade Electrode, Holster, E2250HNSB Valleylab Straight Micro-Needle Electrode, 3 cm, E1651 Edge Pencil Blade Electrode, Holster, E2250H Edge Blade Electrode, (6.5" (, 16.51 cm), E1450-6 and E1450-6NSB Edge Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS Edge Insulated Needle Electrode, Safety Sleeve, (2.8", (7.2 cm), E1465B and E1465BNSB ILAN Surgiwip TRUCLEAR ULTRA MINI Tissue Removal Device Veriset Topical Tissue Adhesives Endo GIA Reload SILS Stitch Endo GIA Reinforced Reload Tristaple Technology PDB VersaOne Bladeless and Optical 15mm Dermalon & Surgilon Minisite Blunt probe Valleylab Argon Handset, E2520H Valleylab Flexible Argon Electrode Coagulation Only, E2530-3 Valleylab Flexible Argon Electrode Coagulation Only, E2530-6 Valleylab Argon Tungsten Sharp Needle Electrode, E2532 Valleylab Flexible Laparoscopic Argon Electrode Coagulation Only, E2530-28 Lectrovac, Valleylab Models Valleylab Suction Coagulator, E2608-6 iDrive Ultra GIATM Stapler with Tri-StapleTM Technology Endo Clip lll Indermil EEA Hemorrhoid stapler and Accessor AUTOSUTURE ENDOSCOPIC CLAMP Signia Small Diameter Reload Spray Shield Spray Gel SurgiPro II Versaport V2 ACUCLIP iDrive Ultra Spacekeeper LigaSure Impact Curved, Large Jaw, Open Sealer/Divider Nano-coated, LF4418 Valleylab REM patient return electrode cord Polyhesive II Patient Return Electr REM patient return electrode cord Valleylab REM Patient Return Electrode Cord, Reusable, 15' (4.6 m), E0560 Valleylab REM Polyhesive Adult Cordless Patient Return Electrode, E7509B Valleylab Cord Clamp ERBE, Reusable 15/ (4.6 m), E0560E Valleylab REM Polyhesive Adult Cordless Patient Return Electrode, E7509 SURGIPORT SPIRAL SLEEVE General Non-Sterile Surgical Inst TRUCLEAR INCISOR" Tissue Removal Device TRUCLEAR Control Unit TRUCLEAR Tissue Removal System TRUCLEAR Operative Hysteroscope 8 TRUCLEAR Sheath 9 TRUCLEAR Obturator TRUCLEAR Footswitch TRUCLEAR Operative Hysteroscope 8- Refurbished/Service TRUCLEAR Handpiece TRUCLEAR INCISOR" Plus Tissue Removal Device Cool-Tip Generator Monosof Polysorb TRUCLEAR Calibration Insert 4 Clearify Force FX Force FX Electrosurgical Generator 8CS, Force FX-8CS Force FX Electrosurgical Generator 8CAS Autobipolar, Force FX-8CAS Force FX Electrosurgical Generator 8C, Force FX-8C Valleylab Solid Laparoscopic Electrode, Wire L-Hook Solid, 45 cm, E2773-45 Valleylab Laparoscopic Cylindrical Electrode, Hollow, 28 cm, E2786-28 Valleylab Laparoscopic Handset, Four-Function, E2750 and E2750NSB Valleylab Solid Laparoscopic Electrode, Flat L-Hook Solid, 36 cm, E2774-36 Valleylab Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2782R-28ASP Valleylab Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Holes, 28 cm, E2781R-28ASP Valleylab Laparoscopic Flat L-Hook Electrode, Hollow, 28 cm, E2784-28 Valleylab Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 36 cm, E2783R-36ASP Valleylab Laparoscopic Wire L-hook Electrode, Hollow, 28 cm, E2783-28 Valleylab Solid Laparoscopic Curved Spatula Electrode, Solid, 36 cm, E2771-36 Valleylab Laparoscopic Wire J-hook Electrode, 28 cm, E2782-28 Valleylab Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 28 cm, E2783R-28ASP Valleylab Laparoscopic Curved Spatula Electrode, Hollow, 28 cm, E2781-28 Valleylab Laparoscopic Straight Spatula Electrode, Hollow, 28 cm, E2780-28 Valleylab Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2784R-28ASP Valleylab Solid Laparoscopic Electrode, Wire J-Hook Solid, 36 cm, E2772-36 Valleylab Solid Laparoscopic Electrode, Wire L-Hook Solid, 36 cm, E2773-36 Valleylab Solid Laparoscopic Curved Spatula Electrode, Solid, 45 cm, E2771-45 Valleylab Solid Laparoscopic Straight Spatula Electrode, Solid, 36 cm, E2770-36 Minisite Biopsy Clearify Trocar Wipe Surgiclip" Autosonix Surgiwand II MINI STEP Miniport Navigator Copilot Reusable Handswitching Pencil Valleylab Rocker Switch Pencil ERBE, Reuseable, E2100E Valleylab Rocker Switch Pencil Reusable, E2100 Minisite Bipolar Forceps LigaSure Tissue Fusion Footswitch, Purple, LS0300 Premium Surgiclip Valleylab Monopolar Footswitch Valleylab Monopolar Footswitch, E6008B Valleylab Monopolar Footswitch, E6008L LigaSure Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644 SILS EGIA Radial Reload ReliaCatch Bralon & Surgidac Caprosyn ENDO SHEARS Polyhesive Patient Return Electrode Valleylab REM Polyhesive Adult Patient Return Electrode, E7507 Valleylab REM Polyhesive Adult Cordless Patient Return Electrode, E7508 Valleylab REM Polyhesive Adult Patient Return Electrode, E7507DB Valleylab Non-REM Polyhesive Patient Return Electrode, E7506 Versastep LigaSure Advance Tacker System Absorbatack STAT Tack Protack MULTAVAC Smoke Evacuation Attachment for Ele Valleylab Rocker Switch Pencil Holster, Smoke Attachment, E2515HS and E2515HSNSB Valleylab Button Switch Pencil Holster, Smoke Attachment, E2516HS Electrodes Valleylab Button Switch Pencil Needle Electrode, Holster, E2516HDA Valleylab Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB Valleylab Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB Valleylab Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB Valleylab Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB Valleylab Button Switch Pencil, E2516, E2516GNSB, and E2516NSB Versaport Bladeless VersaOne Bladed and Bladeless Trocars MIBB SITE MARKER SILS Procedure Kit ENDO MINI-RETRACT TriTis Absorbable SFS Stapler McKesson Skin Staplers 35 REGULAR Appose Skin Staplers Signet McKesson Skin Staplers 35 WIDE ConcordeMultifire Premium skin stapler Umbilical Tape Polysorb Coated Braided Absorbable Suture Premium Poly CS Tri-StapleTM 2 Circular Reloads iDrive Ultra Sterilization Tray VERSAPORT ArthroPort VERSASEAL Ogden Anchore VersaOne 5mm bladed trocar EGIA AVM Model E2515 Electrosurgical Accesso LigaSure Signia Sterilization Tray CHEMOSITE TUNNELER ILA GIA Staplers Versaport Bladeless LigaSure V-Loc 90 Paramount Mini Laparoscope EGIA Ultra Black LigaSure Blunt Tip Open Sealer/Divider Nano-coated, LF1823 LigaSure Blunt Tip, Laparoscopic Sealer/Divider Nano-coated, LF1837 and LF1844 Versastep V2 Blunt Tip Trocars Hugo Robotically Assisted Surgery (RAS) System Dexon MULTAPPLIER Endo Clip MultApplier CLIP IMPLANTABLE TiCron Navigator GPS Extra View Sterile Balloons AS Meniscal TruClear Hysteroscope Duo Poly Surgiclip EEA OrVil Ez-Tack Biosyn AS Meniscal Chemosite Valtrac Purse String Signia" Four-Bay Smart Charger SURGINEEDLE Thoracoport Novafil & Vascufil Gynecology Instrument Tray GYN-Pump PH304 V-Loc Reloads V-Loc 180 Tri-StapleTM 2 Circular Reloads Lapro-Clip Tissue Approximating Forceps Sonicision 26cm dissector (SCD26) Sonicision 28 cm dissector (SCD48) Absorbatack SURGIWAND Stratis ST Absorbable BLUNTGRIP - SURGIGRIP Stainless Steel Sutures LigaSure Maryland Jaw Thoracic Sealer Divider One-step Sealing, Nano-coated (LF1930T) SurgiSleeve Extra Small Wound Protector iDrive Powered Stapling System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-03-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-03-19
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-03-19
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	1994-04-11
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-01-02
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-15
ORQ	Mesh, Surgical, Deployer	General, Plastic Surgery	Class 2	878.3300	2013-06-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	1997-12-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-11-20
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2010-10-20
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2009-01-14
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2007-11-16
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2012-10-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-03-24
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	1999-12-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-04-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-08-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-02-01
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2024-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-12-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-11-01
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-11-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-16
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2011-08-22
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2026-04-16
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2026-04-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-02-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-12-03
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-12-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-10-19
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-10-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2007-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-12-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2012-06-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2014-11-14
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-09-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-02-08
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	1994-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-03-06
FHM	Apparatus, Suturing, Stomach And Intestinal	General, Plastic Surgery	Class 1	878.4800	2007-04-24
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-04-24
NQR	Sealant, Dural	Unknown	Class 3	N/A	2009-11-03
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2009-05-06
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	1997-12-04
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-02
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-01-02
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2007-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2010-12-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-15
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-11-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-11-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2018-07-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-03-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-08-18
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-03-12
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1994-04-11
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2007-04-20
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	1997-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-03-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-12-05
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2007-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-02-26
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2007-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-12-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-06
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-15
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2020-02-28
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2016-06-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-11-20
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2009-05-06
ORQ	Mesh, Surgical, Deployer	General, Plastic Surgery	Class 2	878.3300	2014-02-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-02-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-03-01
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2012-09-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-12-18
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2012-11-14
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2012-11-14
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2008-01-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2009-08-20
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2007-04-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-09-19
MCN	Barrier, Absorbable, Adhesion	Unknown	Class 3	N/A	2009-01-19
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	1997-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-01-09
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2008-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2007-04-24
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2007-12-13
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-16
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-11-16
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-10-24
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2014-10-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-09-18
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-09-27
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2007-11-16
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2008-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1997-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2007-12-10
BWA	Unit, Electrosurgical And Coagulation, With Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-03-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-03-21
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2011-03-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2011-08-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-12-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-11-16
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-16
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1997-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2009-08-12
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2009-08-12
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2007-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-05-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-07-06
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	1997-03-06
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-01-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-03-19
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-03-19
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2007-12-10
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2005-09-12
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-12-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-01-11
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-09-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-16
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2007-11-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-11-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-01-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2011-08-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-07-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2016-09-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-04-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-05-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-20
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2010-06-29
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-12-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-08-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2009-12-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-01-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
SCV	Modular Electromechanical Surgical System	General, Plastic Surgery	Class 2	878.4964	2025-12-05
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-11-16
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2006-04-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-11-16
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2015-12-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2009-01-14
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-03-04
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-03-04
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2009-12-07
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2007-11-16
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-16
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-11-16
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2009-08-12
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-11-16
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2008-01-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-03-06
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	1994-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-11-16
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-08-15
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2023-03-17
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2023-03-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-05-01
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-05-01
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2012-05-01
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-08-18
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2026-01-22
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2015-03-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2008-01-03
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-12-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2009-08-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1997-12-04
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-03-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-03-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	1997-12-04
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2007-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-06-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-03-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-03-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2011-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Covidien llc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19
K142547	Covidien	Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm	2014-12-09
K130320	Covidien	BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW	2014-02-04
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0006-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0007-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0008-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0009-2021	N/A	2	Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0329-2016	Covidien LLC	2	Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0330-2016	Covidien LLC	2	Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0331-2016	Covidien LLC	2	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0332-2016	Covidien LLC	2	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0333-2016	Covidien LLC	2	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0364-2017	Covidien LLC	2	Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Z-0365-2017	Covidien LLC	2	Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Z-0366-2017	Covidien LLC	2	Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Z-0392-2010	Surgical Devices/Covidien	2	SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, product code Surg300; Operator Manual, product code OPMA.
Z-0393-2010	Surgical Devices/Covidien	2	Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular Stapler 33 mm Digital Loading Unit, product code CS33.
Z-0394-2010	Surgical Devices/Covidien	2	Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digital Loading Unit, product code RALC45.
Z-0395-2010	Surgical Devices/Covidien	2	Remote Control Unit with Wire, product code RCW100.
Z-0396-2010	Surgical Devices/Covidien	2	Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4.
Z-0397-2010	Surgical Devices/Covidien	2	FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product code FS214RC; Manual Release for FlexShaft II & III, product code MR14.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219930. Last updated year: 2026. Please use registration number 1219930 when referencing this establishment in official correspondence.