Clearance Summary
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 received FDA 510(k) clearance under submission number K911154, sponsored by Sun Medical, 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 1991-07-26.
- Submission: K911154
- Applicant / Sponsor: Sun Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5070
- Decision date: 1991-07-26
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.