Clearance Summary
SURG/ASSIST MODEL SA-1 received FDA 510(k) clearance under submission number K912422, sponsored by Surg-Assist, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1991-08-12.
- Submission: K912422
- Applicant / Sponsor: Surg-Assist, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5070
- Decision date: 1991-08-12
Classification & Regulation
This clearance is catalogued under FDA product code FYD and 21 CFR 878.5070, within the General, Plastic Surgery review panel as a Class II device.