Data / Medical devices / United States / Covidien

Covidien: FDA-registered device maker in Ponce, PR, United States, 85 510(k) clearances

Name: Covidien FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Covidien is registered with the FDA (registration 2647580) in Ponce, PR, United States. It lists 27 device types. The FDA files 85 510(k) clearances under its listings, the newest dated April 10, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2647580
Address: Building 911-67 Sabanetas Industrial Park, Ponce, PR, United States, 00731
Owner or operator: Covidien llc (1282497)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: April 11, 1994
Registered through: 2026
Brand names listed: ACUCLIP, ANTI-FOG, AUTO SUTURE ENDO CATCH SPECIMAN BAG, AUTOSUTURE ENDOSCOPIC CLAMP, Absorbatack, Appose Skin Staplers, ArthroPort, Auto Suture and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Accessories, Cleaning, For Endoscope	FEB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Apparatus, Suturing, Stomach And Intestinal	FHM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applier, Staple, Surgical,	GEF	1	Manufacturer	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer	accessdata.fda.gov
Clip, Implantable	FZP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	KDW	1	Manufacturer	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Manufacturer	accessdata.fda.gov
Forceps, Obstetrical	HDA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pneumoperitoneum Needle	FHO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Staple, Implantable	GDW	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Manufacturer	accessdata.fda.gov
Stapler, Surgical	GAG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Manufacturer, Specification developer	accessdata.fda.gov
Suture Kit	OVN	2	Manufacturer	accessdata.fda.gov
Trocar, Gastro-Urology	FBQ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K253657	Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads	GDW	Substantially Equivalent	Covidien (Part of Medtronic)	accessdata.fda.gov
October 27, 2023	K231934	GIA Stapler with Tri-Staple Technology	GAG	Substantially Equivalent	Covidien	accessdata.fda.gov
August 16, 2023	K232126	EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil	GAG	Substantially Equivalent	Covidien	accessdata.fda.gov
August 16, 2023	K231491	TA Stapler and Loading Unit with DST Series Technology	GAG	Substantially Equivalent	Covidien	accessdata.fda.gov
November 30, 2022	K221771	EEA Circular Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
September 30, 2022	K221003	Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
May 5, 2022	K221013	GIA Auto Suture Stapler with DST Series Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
April 29, 2022	K221006	GIA Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
April 29, 2022	K221005	EEA Circular Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
January 21, 2021	K202507	EEA Circular Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
December 7, 2020	K202701	GIA Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
March 13, 2020	K192720	GIA Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
January 23, 2020	K192330	EEA Circular Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
February 16, 2018	K172361	EEA Circular Stapler with Tri-Staple Technology	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
October 18, 2016	K162584	VersaOne Bladeless Trocar	GCJ	Substantially Equivalent	Covidien	accessdata.fda.gov
September 14, 2015	K143644	Premium Surgiclip¿; Endo Clip¿; AcuClip¿	FZP	Substantially Equivalent	Covidien	accessdata.fda.gov
June 18, 2015	K151356	Spacemaker Pro Access and Dissector System	GCJ	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
October 30, 2014	K142869	Premium Surgiclip III	FZP	Substantially Equivalent	Covidien	accessdata.fda.gov
February 5, 2013	K122781	RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD	GDW	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H	accessdata.fda.gov
October 25, 2011	K111825	ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS	GDW	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H	accessdata.fda.gov
April 26, 2010	K100548	VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP	GCJ	Substantially Equivalent	Covidien Lp, Formerly Registered AS Tyco Healthcar	accessdata.fda.gov
May 14, 2009	K090470	AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES	OCW	Substantially Equivalent	Covidien	accessdata.fda.gov
May 23, 2008	K081169	AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR	GCJ	Substantially Equivalent	Covidien Lp, Formerly Registered AS United States	accessdata.fda.gov
October 23, 2006	K062850	AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 5, 2006	K062779	DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)	GCJ	Substantially Equivalent	New Wave Surgical Corporation	accessdata.fda.gov
September 1, 2006	K062326	AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 24, 2004	K042412	MODIFIED SPACEMAKER SYSTEM	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
December 19, 2001	K013860	AUTO SUTURE SURGICAL STAPLES	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 6, 2001	K012539	VERASTEP	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
December 8, 2000	K001895	AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 5, 1999	K993055	DEXIDE BIPOLAR FORCEPS II** DEVICE	GEI	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
July 30, 1999	K992288	AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE	GCJ	Substantially Equivalent	Tyco Intl. (Us), Inc.	accessdata.fda.gov
July 29, 1998	K981941	MULTAPORT CANNULA REDUCER AND ACCESSORIES	GCJ	Substantially Equivalent	Dexide, Inc.	accessdata.fda.gov
January 16, 1998	K973046	SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK	GCJ	Substantially Equivalent	General Surgical Innovations	accessdata.fda.gov
September 19, 1997	K972415	MINISITEBIPOLAR FORCEPS* DEVICE	GEI	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
April 21, 1997	K970754	INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP	GCJ	Substantially Equivalent	Innerdyne, Inc.	accessdata.fda.gov
February 12, 1997	K963115	TROCAR CANNULA	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 25, 1996	K961771	AUTO SUTURE SURGIWAND	GEI	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
July 10, 1996	K961940	INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP	GCJ	Substantially Equivalent	Innerdyne, Inc.	accessdata.fda.gov
May 28, 1996	K961430	INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP	GCJ	Substantially Equivalent	Innerdyne, Inc.	accessdata.fda.gov
December 20, 1995	K954853	AUTO SUTURE SUTURE CLOSURE	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
November 9, 1995	K954175	DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]	GCJ	Substantially Equivalent	Origin Medsystems, Inc.	accessdata.fda.gov
October 17, 1995	K954108	MODIFIED VERSAPORT	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 15, 1995	K953611	DEXIDE ENDO-LUBE KIT	GCJ	Substantially Equivalent	Dexide, Inc.	accessdata.fda.gov
July 17, 1995	K952977	SABRE MULTI-USE TROCAR SYSTEM	GCJ	Substantially Equivalent	Endoscopic Concepts, Inc.	accessdata.fda.gov
May 12, 1995	K950658	INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:	GCJ	Substantially Equivalent	Innerdyne, Inc.	accessdata.fda.gov
May 12, 1995	K950632	INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP	GCJ	Substantially Equivalent	Innerdyne, Inc.	accessdata.fda.gov
May 3, 1995	K951589	MANUAL SURGICAL INSRUMENT	GEI	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
January 5, 1995	K946002	ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA	GEX	Substantially Equivalent	Origin Medsystems, Inc.	accessdata.fda.gov
September 20, 1994	K944249	AUTO SUTURE* ANTI-FOG DEVICE**	FEB	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 7, 1994	K943976	SABRE ULTIMATE SHIELDED TROCAR	GCJ	Substantially Equivalent	Endoscopic Concepts, Inc.	accessdata.fda.gov
March 25, 1994	K923843	FOGLESS	OCT	Substantially Equivalent	Sorex Medical	accessdata.fda.gov
February 17, 1994	K935086	AUTO SUTURE DISPOSABLE OPTICAL TROCAR	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
January 26, 1994	K935426	PREPERITONEAL DISTENTION BALLOON SYSTEM	GCJ	Substantially Equivalent	Origin Medsystems, Inc.	accessdata.fda.gov
December 10, 1993	K931962	NON-ABSORBABLE GAUZE	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
July 9, 1993	K924011	ORIGIN BLUNT TIP SURGICAL TROCAR	GCJ	Substantially Equivalent	Origin Medsystems, Inc.	accessdata.fda.gov
April 23, 1993	K925860	MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
January 26, 1993	K925149	AUTO SUTURE ENDOSCOPIC KNOT PUSHER	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 28, 1992	K915338	CONDUCTIVE SURGIGRIP SPIRAL SLEEVE	HET	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 17, 1992	K920068	AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
July 15, 1992	K920599	HOOK SURGICAL INSTRUMENT	GCJ	Substantially Equivalent	Origin Medsystems, Inc.	accessdata.fda.gov
June 11, 1992	K914753	AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP	GET	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
June 11, 1992	K914752	AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
May 6, 1992	K914190	AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR	GAD	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 28, 1991	K913762	MONOSCOPY(TM) BRAND, ENDOBAG	GCJ	Substantially Equivalent	Dexide, Inc.	accessdata.fda.gov
September 19, 1991	K912097	AUTO SUTURE ENDOSCOPIC FASCIA STAPLER	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
February 11, 1991	K910192	AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
January 16, 1991	K905587	AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE	FZP	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 30, 1990	K904578	MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP	GET	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 17, 1990	K903206	AUTO SUTURE(R) ENDOSCOPIC SCISSORS	HET	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 11, 1990	K903205	AUTO SUTURE(R) ENDOSCOPIC CLAMP	HDA	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 25, 1990	K903207	AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE	HET	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
August 9, 1990	K903419	MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE	GDH	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
April 9, 1990	K901107	MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC	GDJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
April 4, 1990	K900123	AUTO SUTURE SURGIPORT SPIRAL SLEEVE	FBQ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
February 27, 1990	K900129	MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
April 7, 1989	K890941	MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP	GDO	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
February 3, 1989	K885222	PRECISE ILA AND ILAN SURGICAL STAPLES	GDW	Substantially Equivalent	3M Company	accessdata.fda.gov
October 2, 1986	K863330	DISPOSABLE PNEUMOPERITONEUM NEEDLE	FHO	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
January 14, 1986	K855047	AUTO SUTURE TITANIUM SURGICAL STAPLES	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 19, 1985	K853650	AUTO SUTURE TITANIUM HEMOSTATIC CLIP	FZP	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 31, 1984	K843603	AUTO SUTURE POLY GIA SURGICAL STAPLER	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
September 25, 1984	K843312	AUTO SUTURE SURGICLIP DISPOS. CLIP APPL		Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
August 4, 1980	K801590	AUTO SUTURE DISPOSABLE GIA SURG. STAPLER	FHM	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
August 4, 1980	K801589	AUTO SUTURE DISP. 30, ETC. & SURG. STAP	FHM	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 5, 2021	87542	Class II	Ongoing	Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094	Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connectin	accessdata.fda.gov

Compare with other makers

Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.