Clearance Summary
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation received FDA 510(k) clearance under submission number K232610, sponsored by Intuitive Surgical, 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 2024-03-14.
- Submission: K232610
- Applicant / Sponsor: Intuitive Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2024-03-14
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.