Clearance Summary
Rezum System received FDA 510(k) clearance under submission number K262460, sponsored by Boston Scientific. 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 2026-09-03.
- Submission: K262460
- Applicant / Sponsor: Boston Scientific
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2026-09-03
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.