Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612501

FEI Number

3003495548

Entity Name

Covidien

City/State/Country

- Santo Domingo, DO

Establishment Address

ZONA FRANCA DE SAN ISIDRO, Carretera San Isidro, Km 17, - Santo Domingo -, DO

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Micro-Craft System XOMED Silicone Block/Strip Clearify ENDO CLOSE Nasal Splint Hydroxylapatite Ossicular Replacement Prosthesis Trans-Nasal Esophogoscope EndoSheath System SURGIPORT Shea Middle Ear Microdrill SurgiGut SURGIPORT SPIRAL SLEEVE Thoracoport VARI-STIM III Nerve Locator Sofsilk Versaport Bladeless Optical Trocar VersaOne Bladeless Trocar Endo Clip III Neuray Surgical Patties and Strips Hoffman N/V coated longer term VT (w/Liner) Strata NSC Burr Hole Valve, Model 42335, Shunt Assembly, Model 46635 Total Ossicular Replacement Posthesis Juhn Tym-Tap Tube-Stat Lighted Intubation Stylets, Naso-Tracheal; Oro-Trachel Stylet ENDO SLIDE ENDO STITCH Intracranial Pressuring Monitoring Syst. PS Medical Button Valve Blunt Tip Trocars Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102 Surgiwip MULTAPPLIER Endo Clip MultApplier CLIP IMPLANTABLE CSF-FLOW CONTROL VALVE, ULTRA SMALL STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 SFS Stapler McKesson Skin Staplers 35 REGULAR Appose Skin Staplers Signet McKesson Skin Staplers 35 WIDE ConcordeMultifire Premium skin stapler PRISMA DISPOSABLE U-SHAPED CANNULA Polysorb Coated Braided Absorbable Suture TiCron PS Medical Delta Burr Hole Valve Surgiclip" Versastep Nicolet Disposable Prass Probe Total Ossicular Replacement Concentric Needle Electrode VersaOne 5mm bladed trocar Epistaxis Balloon CSF-Ventriculostomy Reservoir Versaport V2 Bladeless Optical Trocar Step Austin Modified Ttotal Ossicular replacement SurgiTie Gut Fish Modified Total Ossicular Prosthesis Polypropylene Suture Austin Modified Total Ossicular Replacement VersaOne optical trocar with fixation balloon cannula VersaOne universal fixation balloon cannula Total Ossicular Replacement Trans-Nasal Esophogoscope EndoSheath System Versaport RPF ENDO MINI-RETRACT Total Occicular replacement Rebar IPI Algo-Line Catheter Surgical Nerve Stimulator/Locator ENDO CATCH PS MEDICAL DELTA CSF-FLOW CONTROL VALVE P-S Med. Lumbo Peritoneal & Ventriculo Visiport Versaport Bladeless NIM PRS IPC Powerease System Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 ahd 41704-41715 P-S Medical CSF-Lumboperitoneal Shunt CSF-Ventricular Catheter, Standard Des McGee Modified SS Piston Maxon Activent Ventilation Tube Dermalon & Surgilon P-S Medical CSF-Flow Control Valve Bur Nerve Integrity Monitor 3 Medtronic PS Medical Niveau Drainage System, Pole Clamp Versaport Bladeless VersaOne Bladeless and Optical 15mm One Step DG Surgilene Suture P-S Medical Ventricular Access Port CSF-Flow Control Valve, Ultra Small Versaport v2 MicroRuler, ENT Rebar P-S MEDICAL CSF-FLOW CONTROL VALVE Bluntport Sofsilk Coated Braided Silk Suture Doubletime Trocar Electric Drill System, IPC Endo GIA Pancreas Indication Caprosyn Bucket Prosthesis P-S CSF-Ventricular Catheter, Flanged Nerve Intergrity Monitor - 2XL (NIM 2XL) PS Medical Bioglide CSF-Flow Control Shunt Kit Ventilation (Tympanostomy) Tubes CSF-Cardiac/Peritoneal Catheter Suture Convenience Kit P-S Medical CSF-Siphon Control Device Becker External Drainage/Monitor SYS Lumbar Cath. Monosof Clearify Trocar Wipe Strata BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Echelon P-S Medical CSF Access Dev 15MM/25MM TriVantage Next Generation EMG Endo Tracheal Tube VERSAPORT ArthroPort VERSASEAL VersaOne Bladed and Bladeless Trocars Medtronics PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter, 20CM and 35 CM Model 96115 and 96118 SurgiPro II StrataMR II Valves and Shunts

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2018-05-11
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2022-07-13
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2018-05-11
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2018-05-10
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2018-05-11
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-04-24
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2018-05-11
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	1997-12-04
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2007-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2021-04-07
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2007-11-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-04-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-11-04
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2010-03-05
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2010-03-05
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2018-04-27
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2018-05-11
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2018-05-11
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2018-05-11
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2018-04-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	1994-07-11
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2018-05-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
HCA	Catheter, Ventricular	Neurology	Class 2	882.4100	2018-05-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-06
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2006-04-26
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-03
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2007-12-10
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-07-12
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-12-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-11-16
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-09-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-05-11
LBN	Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene	Ear, Nose, Throat	Class 2	874.3495	2018-05-10
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2018-05-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-01-22
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2018-05-10
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	Class 2	882.5550	2018-05-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-09-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
LBM	Porous Polyethylene Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2018-05-10
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2007-04-24
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2011-07-13
LBM	Porous Polyethylene Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2018-05-10
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2010-10-20
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2018-05-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-06-29
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2018-05-10
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2018-05-11
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	2005-04-19
LFB	Button, Nasal Septal	Unknown	Class U	N/A	2018-05-10
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-06-02
MAJ	Catheter, Percutaneous, Intraspinal, Short Term	Anesthesiology	Class 2	868.5120	2018-05-04
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-04-30
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2007-04-20
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-03
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
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	2008-05-28
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-12-13
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-05-11
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2018-05-11
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-05-11
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2018-05-11
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-11-16
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2018-05-11
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-16
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-04-27
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-04-27
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2018-05-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
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	2016-03-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	1999-12-09
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	Class 2	882.5550	2018-05-04
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-12-14
KAH	Microrule, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-05-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-06-02
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-12-09
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2025-09-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-03-23
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2018-05-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-05-11
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-05-11
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2018-05-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2012-06-04
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-11-16
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2018-05-11
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-04-27
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2018-05-11
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2016-02-19
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-16
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-09-18
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2021-06-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-03
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2018-05-03
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-06-02
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	Class 2	882.5550	2018-05-04
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-05-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-05-04
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	1997-12-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2022-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

Wing Ng Email: wing.k.ng@medtronic.com Phone: (508) 2616596

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-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612501. Last updated year: 2026. Please use registration number 9612501 when referencing this establishment in official correspondence.