Clearance Summary
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT received FDA 510(k) clearance under submission number K112584, 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 2011-09-29.
- Submission: K112584
- Applicant / Sponsor: Intuitive Surgical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-09-29
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.