Medical Device Manufacturer · GB , Deeside

Convatec Limited

9 submissions · 8 cleared · Since 2016
9
Total
8
Cleared
0
Denied

Convatec Limited — FDA 510(k) Submissions

Convatec Limited has submitted 9 FDA 510(k) premarket notifications since 2016, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Urethral, Dressing, Wound, Drug, Catheter, Urological, Tubes, Gastrointestinal (and Accessories), Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
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
K250891 · FCM Tray, Catheterization,... · Gastroenterology & Urology
Jun 2025 73d
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · GBM Catheter, Urethral · Gastroenterology & Urology
Jun 2022 264d
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
K190114 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Apr 2019 96d
AVELLE Negative Pressure Wound Therapy System
K180205 · OMP Negative Pressure Wound... · General & Plastic Surgery
Oct 2018 268d
GentleCath Glide Intermittent Urinary Catheter
K181206 · GBM Catheter, Urethral · Gastroenterology & Urology
Aug 2018 101d
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
K173675 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Jul 2018 232d
GentleCath Intermittent Urinary Catheter
K172924 · KOD Catheter, Urological · Gastroenterology & Urology
Nov 2017 57d
GentleCath Glide Intermittent Catheter
K161344 · KOD Catheter, Urological · Gastroenterology & Urology
Sep 2016 130d
AQUACEL Ag Surgical SP Dressing
K152926 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Jan 2016 108d
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