Clearance Summary
CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG received FDA 510(k) clearance under submission number K914883, sponsored by Circon Video. 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 1993-01-15.
- Submission: K914883
- Applicant / Sponsor: Circon Video
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1993-01-15
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.