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Convatec

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) 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).EZD2026-08-05 View
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)EZD2025-07-01 View
510(k) K243228 Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28 View
510(k) K232665 GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25 View
510(k) K162906 Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07 View
510(k) K083785 VITALA CONTINENCE CONTROL DEVICEEZQ2010-04-02 View
510(k) K091034 AQUACEL AG SURGICALFRO2009-12-16 View
510(k) K071763 AMADEUS ADAPTIVE COMPRESSION THERAPYJOW2008-03-07 View
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