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Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

FDA product code FCM · 60 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5130
Review panel
GU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-10-07 – 2026-05-29
FCM 2025-06-06

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

Applicant Convatec Limited

K number K250891

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