Clearance Summary
ENCLOSE II ANASTOMOSIS ASSIST DEVICE received FDA 510(k) clearance under submission number K032589, sponsored by Novare Surgical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-09-05.
- Submission: K032589
- Applicant / Sponsor: Novare Surgical Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2003-09-05
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.