Clearance Summary
GEM Flow COUPLER Device and System received FDA 510(k) clearance under submission number K143589, sponsored by Synovis Life Technologies, Inc.. 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 2015-01-16.
- Submission: K143589
- Applicant / Sponsor: Synovis Life Technologies, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2015-01-16
Classification & Regulation
This clearance is catalogued under FDA product code MVR and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.