Clearance Summary
RF Vapor System received FDA 510(k) clearance under submission number K213627, sponsored by Aqua Medical, Inc.. 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 2021-12-17.
- Submission: K213627
- Applicant / Sponsor: Aqua Medical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2021-12-17
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.