Clearance Summary
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection received FDA 510(k) clearance under submission number K233645, sponsored by Boston Scientific 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 2023-12-12.
- Submission: K233645
- Applicant / Sponsor: Boston Scientific Corporation -
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-12-12
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.