Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1717344

FEI Number

1717344

Entity Name

Covidien

City/State/Country

BOULDER, CO, US

Establishment Address

6044 Longbow Court, BOULDER, CO 80301, 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

K904560

PMA Number

N/A

All Registered Proprietary Names

Covidien Valleylab Straight Extension Valleylab Needle Electrode Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm),E1003 Valleylab Ball Electrode Valleylab Blade Electrode Valleylab Straight Extension, 34.3 cm, E1504 Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm),E1551XNSB Valleylab Straight Extension, 13 cm, E1502 Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm,E1005 Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB Valleylab Ball Electrode, Reusable, 3.2 mm, E1000 Valleylab Ball Electrode, Reusable, 5.6 mm, E1002 Valleylab Ball Electrode, 5 mm, E1550 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552 ReliantTM Button Switch Pencils, Coated Blade, Holster; VL2615, VL2615DB, VL2615E, VL2615NSB Cool-Tip RF System ForceTriad Electrosurgical Generato Suction Coagulators RapidVac ULPA Filter RapidVac Smoke Evacuator 220V, SE3695 RapidVac Smoke Evacuator Filter, SEA3700 RapidVac Smoke Evacuator 110V, SE3690 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 VL2610 Reliant Button Switch Pencil VL2610E, VL2610DB, VL2610NSB Force Argon II System Valleylab Argon Tank Regulator, GR200A-20 Valleylab Argon Tank Regulator, GR200A Valleylab Return Electrode Monitor Valleylab Multiple Return/S Cord Adapter, E0507-B Valleylab FX8 FX Series Energy Platform TissueFect Tissue Sensing Technology, VLFX8GEN Sonicision Reusable Sterilization Tray, SCSTA ForceTriad Remote Control Activation Kit, FTRCKIT Valleylab Laparoscopic Argon Sharp Needle Electrode Retractable, E2582-28 Valleylab Laparoscopic Argon Blade Electrode Retractable, E2580-28 Valleylab Laparoscopic Argon Modified Flat L Electrode Retractable, E2581-28 Valleylab Laparoscopic Argon Blunt Needle Electrode Retractable, E2583-28 Ligasure 5mm Blunt Tip Laparoscopic LigaSure Exact Dissector, Nano-coated, LF2019 LigaSure¿ Single pedal footswitch ForceTriad¿ Electrosurgical Generator ForceTriad¿ Three pedal footswitch Bipolar Footswitch LigaSure Tissue Fusion Footswitch, Orange, LF0500 Valleylab Bipolar Standard Footswitch, E6009 Valleylab REM Polyhesive Neonatal Patient Return Electrode, E7512 LigaSure Maryland Jaw Thoracic Sealer Divider One-step Sealing, Nano-coated (LF1930T) Coated Electrodes Force TriVerse Valleylab REM Polyhesive Infant Patient Return Electrode, E7510-25DB Valleylab REM Polyhesive Infant Patient Return Electrode, E7510-25 Coated Electrodes 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 Force TriVerse Electrosurgical Device Holster 10' (3 m), FT3000 Force TriVerse Electrosurgical Device Holster 15' (4.6 m), FT300DB LigaSure Blunt Tip Open Sealer/Divider, LF1623 LigaSure Blunt Tip Laparoscopic Sealer/Divider, LF1644 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 Cool-tip Valleylab Flexible Laparoscopic Argon Electrode, Coagulation Only, 28 cm, E3530-28 Valleylab Laparoscopic Argon Blade Electrode, Retractable, 28cm, E3580-28 Argon 3" Flexible Electrode, E3530-3 Argon 6" Flexible Electrode, E3530-6 Valleylab Laparoscopic Argon Blunt Needle Electrode, Retractable, 28cm, E3583-28 Valleylab Laparoscopic Argon Modified Flat L Electrode, Retractable, 28cm, E3581-28 Valleylab Flexible Argon Electrode, Coagulation Only, 3" (7.62 cm), E3530-3 Valleylab Flexible Argon Electrode, Coagulation Only, 6" (15 cm), E3530-6 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider Nano-coated, LF4418 Vivawave Microwave System Pencils Model E2515 Electrosurgical Accesso LigaSure¿ Impact LigaSure¿ V Cool-Tip Switching Controller, CTSW Sonicision Sterilization Tray Emprint Microwave Ablation System- CAMSYS Footswitch- RFASW; & Remote Temperature Probe- RTP20 Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1 LigaSure Curved, Small Jaw, Open Sealer/Divider Current Monitor E3351 Current Monitor E3350 LigaSure Exact Dissector Nano-coated, LF2019 Single Use Ground Pad Valleylab monopolar cord Valleylab Monopolar Cord 10' (3 m), E0503 LigaSure Dolphin Tip Laparoscopic Sealer/Divider, LS1500 LigaSure Tissue Fusion Electrode Straight Jaw, LS2071 Ligasure Tissue Fusion Electrode Curved Jaw, LS3112 LigaSure Atlas Tissue Fusion Laparoscopic Instrument, LS1037 LigaSure Tissue Fusion Electrode Angled Jaw, LS2111 LigaSure Vessel Sealing System, LigaSure 8 LigaSure Atlas Tissue Fusion Open Instrument, LS1020 LigaSure Dolphin Tip Laparoscopic Sealer/Divider LigaSure Dolphin Tip Open Sealer/Divider, LS1520 Ligasure Tissue Fusion Electrode Curved Jaw, LS3092 Valleylab Laparoscopic Wire L-Hook Electrode Retractable, Aspiration Holes, 28 cm, E3783R-28ASP Valleylab Laparoscopic Wire J-Hook Electrode Retractable, Aspiration Holes, 28 cm, E3782R-28ASP Valleylab Laparoscopic Wire L-Hook Electrode, Hollow,28cm, E3783-28 Valleylab Laparoscopic Cylindrical Tip Electrode, Hollow,28cm, E3786-28 Valleylab Laparoscopic Curved Spatula Electrode Retractable, Aspiration Holes, 28 cm, E3781R-28ASP Valleylab Laparoscopic Curved Spatula Electrode, Hollow,28cm, E3781-28 Valleylab Laparoscopic Flat L-Hook Electrode Retractable, Aspiration Holes, 28 cm, E3784R-28ASP Valleylab Laparoscopic Wire J-Hook Electrode, Hollow,28cm, E3782-28 Valleylab Laparoscopic Straight Spatula Electrode, Hollow,28cm, E3780-28 Valleylab Laparoscopic Wire L-Hook Electrode Retractable, Aspiration Holes, 36 cm, E3783R-36ASP Force EZ Valleylab Blade Electrode Valleylab¿ Ball Electrode Valleylab¿ Straight Extension Valleylab Needle Electrode Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm, E1005 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB Valleylab Ball Electrode, Reusable, 5.6 mm, E1002 Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm), E1551XNSB Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB Valleylab Straight Extension, 34.3 cm, E1504 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552 Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm), E1003 Valleylab Ball Electrode, Reusable, 3.2 mm, E1000 Valleylab Straight Extension, 13 cm, E1502 Valleylab Ball Electrode, 5 mm, E1550 Force GSU TM System Force GSU TM Handset Valleylab Argon Gas Tank, GT100 Valleylab Smoke Attachment, E3810 and E3815 Covidien Valleylab Monopolar Cord, E10503 Sonicision Torque Wrench Sonicision Cordless Ultrasonic Dissector (5 mm - 48 cm) Sonicision Cordless Ultrasonic Dissector (5 mm - 13 cm) Sonicision Cordless Ultrasonic Dissector Sonicision Reusable Generator Sonicision Cordless Ultrasonic Dissector (5 mm - 26 cm) LigaSure Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644 Sonicision Cordless Ultrasonic Dissector (5 mm 39 cm), SCD396 Sonicision Cordless Ultrasonic Dissector (5 mm 39 cm), SCD391 Sonicision Cordless Ultrasonic Dissector (5 mm - 26 cm), SCD26 Sonicision Cordless Ultrasonic Dissector (5 mm - 13 cm), SCD13 Sonicision Cordless Ultrasonic Dissector (5 mm - 48 cm), SCD48 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 RapidVac Remote Switch Activator (RSA) Cool-tip RF Ablation System E Series 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 Laparoscopic Cord Valleylab Monopolar Laparoscopic Cord Reusable 10' (3 m), E2999 Adapters Valleylab REM Patient Return Electrode Adapter, E0600 Valleylab Monopolar Adapter , E0502-1 Valleylab Universal Monopolar Adapter, E0017 Valleylab Active Adapter, E0005-3C Covidien Valleylab Footswitching Pencil, E3504 Covidien Edge Footswitching Pencil Blade Electrode, Holster, E3250H Covidien Valleylab Footswitching Pencil Holster, E3504H Covidien Valleylab Footswitching Pencil Holster, E3504NSB Covidien Edge Footswitching Pencil Blade Electrode, Holster, E3250HNSB Cool-Tip Generator Lletz Electrodes Valleylab Tungsten Loop Electrode, 20 mm x 15 mm, E1562 Valleylab Tungsten Square Loop Electrode, 5 mm x 5 mm, E1565 Valleylab Tungsten Square Loop Electrode, 10 mm x 8 mm, E1567 Valleylab Tungsten Loop Electrode, 20 mm x 12 mm, E1561 Valleylab Ball Electrode, 5 mm, E1564 Valleylab Tungsten Loop Electrode, 15 mm x 12 mm, E1560 Valleylab Ball Electrode, 3 mm, E1563 Valleylab Tungsten Loop Electrode, 10 mm x 10 mm, E1559 Sonicision 26cm dissector (SCD26) Sonicision 28 cm dissector (SCD48) Reusable Handswitching Pencil Valleylab Rocker Switch Pencil ERBE, Reuseable, E2100E Valleylab Rocker Switch Pencil Reusable, E2100 Laparascopic Electrodes w/Retractab LigaSure Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, LF1737 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, LF4318 LigaSure Maryland Jaw Open Sealer/Divider One-step Sealing, LF1723 LigaSure Blunt Tip Laparoscopic Sealer/Divider, LF1637 LigaSure Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, LF1744 E3773-36C, CleanCoat Laparoscopic Wire L-Hook Electrode Coated, 36cm E3773-45C, CleanCoat Laparoscopic Wire L-Hook Electrode , Coated, 45cm E3774-36, Valleylab Laparoscopic Flat L-Hook Electrode, Solid, 36cm E3773-45, Valleylab Laparoscopic Wire L-Hook Electrode, Solid, 45cm E3771-45, Valleylab Laparoscopic Curved Spatula Electrode, Solid, 45cm E3771-36C, CleanCoat Laparoscopic Curved Spatula Electrode, Coated, 36cm E3771-45C, CleanCoat Laparoscopic Curved Spatula Electrode, Coated, 45cm E3774-45C, CleanCoat Laparoscopic Flat L-Hook Electrode, Coated, 45cm E3770-36, Valleylab Laparoscopic Straight Spatula Electrode, Solid, 36cm E3770-36C, CleanCoat Laparoscopic Straight Spatula Electrode Coated, 36cm E3773-36, Valleylab Laparoscopic Wire L-Hook Electrode, Solid, 36cm E3774-36C, CleanCoat Laparoscopic Flat L-Hook Electrode, Coated, 36cm E3774-45, Valleylab Laparoscopic Flat L-Hook Electrode, Solid, 45cm E3772-36, Valleylab Laparoscopic Wire J-Hook Electrode, Solid, 36cm E3771-36, Valleylab Laparoscopic Curved Spatula Electrode, Solid, 36cm E3772-36C, CleanCoat Laparoscopic Wire J-Hook Electrode, Coated, 36cm LigaSure¿ Atlas ATLAS Valleylab FT10 FT Series Energy Platform, VLFT10GEN Valleylab FT10 Bipolar Adapter, VLFT10ADP1 Valleylab Smoke Evacuation Pencil, Sterile, CVPLP2000 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 Laparoscopic Handswitch/Electrodes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-09-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-11
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-07-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-08-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-05-16
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-07
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-07-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-14
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	2010-02-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-06-25
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	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-20
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-03-13
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	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-27
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-11
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	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-02-21
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2014-05-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-01-23
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	2018-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-26
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2007-12-11
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	2019-09-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2012-05-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-03-13
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-08-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-26
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2014-01-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-02-28
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	2007-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-12-02
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-03-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2021-04-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-02-21
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

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-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1717344. Last updated year: 2026. Please use registration number 1717344 when referencing this establishment in official correspondence.