Data / Medical devices / United Kingdom / Convatec Limited

Convatec Limited: FDA-registered device maker in Deeside Flintshire, United Kingdom, 13 510(k) clearances

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

Convatec Limited is registered with the FDA (registration 1000317571) in Deeside Flintshire, United Kingdom. It lists 20 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 8, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Convatec Limited

FDA registration number: 1000317571
Address: First Avenue DEESIDE INDUSTRIAL PARK, Deeside Flintshire, United Kingdom, CH5 2NU
Owner or operator: ConvaTec (2241599)
Roles: Manufacturer, Specification developer
First device listed: June 1, 1981
Registered through: 2026
Brand names listed: ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive, ACTIVE LIFE One-Piece Closed-End Pouch, ACTIVE LIFE One-Piece Urostomy Pouch Durahesive, AQUACEL Ag, AQUACEL Ag Burn, AQUACEL Ag EXTRA, AQUACEL Ag Foam, AQUACEL Ag with Strengthening Fiber and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Drainage, With Adhesive, Ostomy	FON	1	Manufacturer	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	Manufacturer	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Specification developer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Manufacturer	accessdata.fda.gov
Cement, Stomal Appliance, Ostomy	EZR	1	Manufacturer	accessdata.fda.gov
Collector, Ostomy	EXB	1	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Manufacturer	accessdata.fda.gov
Ostomy Care Kit	PQE	1	Manufacturer	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Manufacturer	accessdata.fda.gov
Protector, Ostomy	EXE	1	Manufacturer	accessdata.fda.gov
Rod, Colostomy	EZP	2	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Manufacturer, Specification developer	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
November 8, 2023	K230400	Cure Catheter Closed System; Cure Dextra Closed System	EZD	Unknown	Convatec, Inc.	accessdata.fda.gov
November 17, 2022	K221593	Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus	EZD	Substantially Equivalent	Convatec, Inc.	accessdata.fda.gov
April 30, 2019	K190114	Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)	KNT	Substantially Equivalent	Convatec Limited	accessdata.fda.gov
July 20, 2018	K173675	AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber	FRO	Substantially Equivalent	Convatec Limited	accessdata.fda.gov
March 7, 2017	K162906	Flexi-Seal PROTECT Fecal Management System	KNT	Substantially Equivalent	Convatec	accessdata.fda.gov
September 20, 2016	K161344	GentleCath Glide Intermittent Catheter	KOD	Substantially Equivalent	Convatec Limited	accessdata.fda.gov
July 21, 2015	K150350	Flexi-Seal Signal Fecal Management System	KNT	Substantially Equivalent	Convatec, Ltd.	accessdata.fda.gov
June 6, 2013	K123481	AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE	FRO	Substantially Equivalent	Convatec, Inc.	accessdata.fda.gov
July 25, 2012	K121275	AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER	FRO	Substantially Equivalent	Convatec, Inc.	accessdata.fda.gov
April 26, 2012	K112342	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM	KNT	Substantially Equivalent	Convatec, Inc.	accessdata.fda.gov
September 4, 2009	K090254	SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)	FRO	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons, LLC	accessdata.fda.gov
May 2, 2008	K080383	AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING	FRO	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons, LLC	accessdata.fda.gov
June 16, 1981	K811240	SUR-FIT LOOP OSTOMY O.R. SET	EXB	Substantially Equivalent	E. R. Squibb & Sons, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 8, 2023. 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.