Clearance Summary
Rezum System received FDA 510(k) clearance under submission number K191505, sponsored by Nxthera (A Boston Scientific Company). The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-08-02.
- Submission: K191505
- Applicant / Sponsor: Nxthera (A Boston Scientific Company)
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2019-08-02
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.