Medical Device Manufacturer · US , Skillman , NJ

Convatec

7 submissions · 7 cleared · Since 2008
7
Total
7
Cleared
0
Denied

Convatec — FDA 510(k) Submissions

Convatec has submitted 7 FDA 510(k) premarket notifications since 2008, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tubes, Gastrointestinal (and Accessories), Catheter, Straight, Sleeve, Limb, Compressible, Pouch, Colostomy, Dressing, Wound, Drug . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
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)
K250699 · EZD Catheter, Straight · Gastroenterology & Urology
Jul 2025 116d
Flexi-Seal AIR (with ENFit Connector)
K243228 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Mar 2025 171d
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
K232665 · EZD Catheter, Straight · Gastroenterology & Urology
Jan 2024 147d
Flexi-Seal PROTECT Fecal Management System
K162906 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Mar 2017 141d
VITALA CONTINENCE CONTROL DEVICE
K083785 · EZQ Pouch, Colostomy · Gastroenterology & Urology
Apr 2010 469d
AQUACEL AG SURGICAL
K091034 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Dec 2009 250d
AMADEUS ADAPTIVE COMPRESSION THERAPY
K071763 · JOW Sleeve, Limb, Compressible · Cardiovascular
Mar 2008 252d
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