Clearance Summary
da Vinci Xi 12 8 mm Reducer received FDA 510(k) clearance under submission number K162411, sponsored by Intuitive Surgical, 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 2016-09-21.
- Submission: K162411
- Applicant / Sponsor: Intuitive Surgical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-09-21
Classification & Regulation
This clearance is catalogued under FDA product code NAY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.