# Convatec Limited

- Location (FDA's records): Deeside, GB
- FDA decisions: 29 (1997–2026): 29 510(k) clearances
- Names in FDA's records: Convatec Limited (10); Convatec (8); Convatec, Inc. (7); Convatec, Ltd. (4)
- Product codes: FRO (7), EZD (6), KNT (5), KOD (3), EZQ (3), GBM (2), OMP (1), JOW (1), FCM (1)
- 510(k) review time since 2016: median 152 days, against 147 for FDA's reviews in the same codes and years (5 of 13 faster)
- Predicates its devices cite: 40 (18 its own); citations of its devices by later devices: 37 (18 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Convatec, A Division of E.R. Squibb & Sons: 4 (https://510kreport.com/company/convatec-a-division-of-er-squibb-sons)
- Cure Medical, LLC: 3 (https://510kreport.com/company/cure-medical)
- Rusch Intl.: 2 (https://510kreport.com/company/rusch-intl)
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Coloplast Manufacturing Us, LLC: 2 (https://510kreport.com/company/coloplast-manufacturing-us)
- Smith & Nephew Medical Limited: 1 (https://510kreport.com/company/smith-nephew-medical)
- Molnlycke Health Care, Inc.: 1 (https://510kreport.com/company/molnlycke-health-care)
- Unoplast A/S: 1 (https://510kreport.com/company/unoplast-a-s)

## Firms that cite its devices most
- Advanced Medical Solutions Limited: 2 (https://510kreport.com/company/advanced-medical-solutions)
- Speciality Fibres and Materials, Ltd.: 2 (https://510kreport.com/company/speciality-fibres-and-materials)
- Johnson & Johnson Medical, Div. of Ethicon, Inc.: 2 (https://510kreport.com/company/johnson-johnson-medical-div-of-ethicon)
- Johnson & Johnson Medical, Inc.: 1 (https://510kreport.com/company/johnson-johnson-medical)
- Genadyne Biotechnologies, Inc.: 1 (https://510kreport.com/company/genadyne-biotechnologies)
- HR Healthcare: 1 (https://510kreport.com/company/hr-healthcare)
- Molnlycke Health Care Us, LLC: 1 (https://510kreport.com/company/molnlycke-health-care-us)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Its most-cited devices
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber (2012), cited by 6
- K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (2018), cited by 4
- K181206: GentleCath Glide Intermittent Urinary Catheter (2018), cited by 3
- K973688: Duoderm Control Gel Formula Border Dressing (1997), cited by 3
- K150350: Flexi-Seal Signal Fecal Management System (2015), cited by 3
- K180205: AVELLE Negative Pressure Wound Therapy System (2018), cited by 2

## Recent decisions
- K260737: Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). (Aug 5, 2026)
- K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (Apr 1, 2026)
- K250699: Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (Jul 1, 2025)
- K250891: Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (Jun 6, 2025)
- K243228: Flexi-Seal AIR (with ENFit Connector) (Mar 28, 2025)
- K232665: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) (Jan 25, 2024)
- K230400: Cure Catheter Closed System; Cure Dextra Closed System (Nov 8, 2023)
- K221593: Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (Nov 17, 2022)

Source page: https://510kreport.com/company/convatec