Clearance Summary
System 83 Revolve Endoscope Washer/Disinfector received FDA 510(k) clearance under submission number K241168, sponsored by Wassenburg Medical, 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 2024-12-19.
- Submission: K241168
- Applicant / Sponsor: Wassenburg Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2024-12-19
Classification & Regulation
This clearance is catalogued under FDA product code FEB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.