Clearance Summary
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS received FDA 510(k) clearance under submission number K071488, sponsored by Novare Surgical Systems, 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 2007-06-29.
- Submission: K071488
- Applicant / Sponsor: Novare Surgical Systems, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2007-06-29
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.