K250699
- 510(k) number
- K250699
- Device name
- 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)
- Applicant
- Convatec GB
- Product code
- EZD — Catheter, Straight
- Decision date
- 2025-07-01
- Date received
- 2025-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250699.pdf
Official FDA record: K250699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.