Clearance Summary
PKS OMNI INSTRUMENT received FDA 510(k) clearance under submission number K081766, sponsored by Gyrus-Acmi L.P.. 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 2008-08-08.
- Submission: K081766
- Applicant / Sponsor: Gyrus-Acmi L.P.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2008-08-08
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.