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Convatec

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest Approval2025-07-01
TypeNumberDevice NameCodeDate
510(k) 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) EZD 2025-07-01 View
510(k) K243228 Flexi-Seal AIR (with ENFit Connector) KNT 2025-03-28 View
510(k) K232665 GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) EZD 2024-01-25 View
510(k) K162906 Flexi-Seal PROTECT Fecal Management System KNT 2017-03-07 View
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