Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2647580

FEI Number

2647580

Entity Name

Covidien

City/State/Country

PONCE, PR, US

Establishment Address

BUILDING 911-67, SABANETAS INDUSTRIAL PARK, PONCE, PR 00731, 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

K953611

PMA Number

N/A

All Registered Proprietary Names

TA Stapler and Loading Unit with DST Series Technology ENDO BAG ENDO GIA ROTICULATOR Staplers ILAN SURGIPORT SPIRAL SLEEVE ILA GIA Staplers ROTICULATOR ENDO MINI-SHEARS Purstring Versastep V2 ENDO SHEARS Radial Expandable Laparoscope Endo GIA Pancreas Indication Spacemaker Balloon Dissector EndoSaph Vein Harvest System Versaport RPF Surgiport EEA Surgical Stapler GIA Stapler with Tri-Staple Technology Surgiwand II ENDO CLOSE AUTOSUTURE ENDOSCOPIC CLAMP Blunt Tip Trocars VERSAPORT ArthroPort VERSASEAL GIA PREMIUM EEA Circular Stapler with DST Series Technology Extra View Sterile Balloons Clearify Premium Surgiclip SURGINEEDLE Endo Universal 65 POLY GIA EEA Circular Stapler with Tri-Staple Technology FRED Premium Surgiclip ENDO MINI-SHEARS Open Step ENDO PEANUT ENDO PADDLE RETRACT Versaport Umbilical Tape GIA Stapler with Tri-Staple Technology EEA Circular Stapler with Tri-Staple Transoral Circular Stapler Anvil Technology and OrVil ACUCLIP GIATM Stapler with Tri-StapleTM Technology SURGICAL DYNAMICS SURGICAL DYNAMICS* One Step EEA Circular Stapler with Tri-Staple Technology EEA Circular Stapler with Tri-Staple Technology Thoracoport Auto Suture Suture Convenience Kit ReliaMax ENDO SLIDE Clearify Trocar Wipe BLUNTGRIP - SURGIGRIP Spacekeeper ANTI-FOG Versaport V2 Endo GIA Reloads with Tri-Staple Technology Signia Small Diameter Reloads Tri-staple 2 Reloads Endo GIA Gray Articulating Reloads GIA Stapler with Tri-Staple Technology EEA'M Circular Stapler with Tri-Staple" Technology Versaport Bladeless Visiport EEA Stapler General Non-Sterile Surgical Inst PDB Sterile Balloon Step PDB AUTO SUTURE ENDO CATCH SPECIMAN BAG GIA Auto Suture Stapler with DST Series Technology, GIA Auto Suture ENDO LUNG Premium-SurgiClip III Surgiclip" Endo Lube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-09-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-09-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-12-14
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	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	2005-04-19
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-01-02
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	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	2015-08-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2012-06-04
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	2007-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	1997-12-04
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-03-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-03-29
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	2005-04-19
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2007-04-24
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	2005-04-19
FHM	Apparatus, Suturing, Stomach And Intestinal	General, Plastic Surgery	Class 1	878.4800	2007-04-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-06-30
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-06-30
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	2014-10-24
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2014-10-24
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	1997-12-04
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	1994-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-01-22
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	1997-12-04
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2007-12-10
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	1997-12-04
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
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1997-03-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2005-09-12
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
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-12-09
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-12-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-12-18
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1996-10-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-01-31
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-12-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-12-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2016-02-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-02-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-04-19
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-09-18
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	1997-12-04
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2008-01-03
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2007-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-14
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
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-04-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2018-03-09
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2018-03-09
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	2007-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2007-12-13
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	2007-12-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-10
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	1994-04-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-02-23
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-02-23
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2007-04-24
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2014-11-14
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-09-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-08-12

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-0070-2019	COVIDIEN LLC	2	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3013942591	INTUITIVE SURGICAL, INC.	Sunnyvale, CA, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
1219930	Covidien	North Haven, CT, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3013188547	ORTA MEDICAL LTD	TZUR YIGAL Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2647580. Last updated year: 2026. Please use registration number 2647580 when referencing this establishment in official correspondence.