Clearance Summary
Transurethral Catheter Safety Valve (TUCSV) (80050) received FDA 510(k) clearance under submission number K260919, sponsored by Class Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-08-05.
- Submission: K260919
- Applicant / Sponsor: Class Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2026-08-05
Classification & Regulation
This clearance is catalogued under FDA product code KNY and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.