Clearance Summary
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT received FDA 510(k) clearance under submission number K974084, sponsored by Getinge/Castle, 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 1998-03-03.
- Submission: K974084
- Applicant / Sponsor: Getinge/Castle, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1998-03-03
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.