Clearance Summary
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 received FDA 510(k) clearance under submission number K223466, sponsored by STERIS Corporation. 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 2023-02-17.
- Submission: K223466
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-02-17
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.