Clearance Summary
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System received FDA 510(k) clearance under submission number K210579, sponsored by OTU 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 2021-07-22.
- Submission: K210579
- Applicant / Sponsor: OTU Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-07-22
Classification & Regulation
This clearance is catalogued under FDA product code FGB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.