K260919
- 510(k) number
- K260919
- Device name
- Transurethral Catheter Safety Valve (TUCSV) (80050)
- Applicant
- Class Medical , Ltd. IE
- Product code
- KNY — Accessories, Catheter, G-U
- Decision date
- 2026-08-05
- Date received
- 2026-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260919.pdf
Official FDA record: K260919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.