Clearance Summary
IS4000 Stapler 30 Instrument and Stapler 30 Reloads received FDA 510(k) clearance under submission number K152421, 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 2016-03-04.
- Submission: K152421
- Applicant / Sponsor: Intuitive Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-03-04
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.