Clearance Summary
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT received FDA 510(k) clearance under submission number K003577, sponsored by STERIS Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-01-29.
- Submission: K003577
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2001-01-29
Classification & Regulation
This clearance is catalogued under FDA product code FST and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.