Clearance Summary
IS4000 8mm Harmonic ACE Curved Shears received FDA 510(k) clearance under submission number K143132, 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 2015-04-02.
- Submission: K143132
- Applicant / Sponsor: Intuitive Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2015-04-02
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.