Clearance Summary
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE received FDA 510(k) clearance under submission number K020470, sponsored by Bypass , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-03-08.
- Submission: K020470
- Applicant / Sponsor: Bypass , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2002-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FZP and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.