Clearance Summary
Optilume Basic Urological Balloon Dilation Catheter received FDA 510(k) clearance under submission number K191061, sponsored by Urotronic, Inc.. 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 2020-01-02.
- Submission: K191061
- Applicant / Sponsor: Urotronic, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5520
- Decision date: 2020-01-02
Classification & Regulation
This clearance is catalogued under FDA product code KOE and 21 CFR 876.5520, within the Gastroenterology, Urology review panel as a Class II device.