Cure Catheter Insertion Kit (K1) +12 more— 510(k) K250891
UnknownConvatec Limited
FDA 510(k) clearance K250891 for Cure Catheter Insertion Kit (K1) +12 more, Unknown on 2025-06-06. Applicant: Convatec Limited. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code
- Code FCM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Flintshire, GB
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Data sourced from openFDA. This site is unofficial and independent of the FDA.