K250891
- 510(k) number
- K250891
- Device name
- 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 GB
- Product code
- FCM — Tray, Catheterization, Sterile Urethral, With Or Wit
- Decision date
- 2025-06-06
- Date received
- 2025-03-25
- Decision
- Unknown
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250891.pdf
Official FDA record: K250891
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.