Clearance Summary
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 received FDA 510(k) clearance under submission number K011693, sponsored by Trumpf Medical Systems, 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 2001-06-13.
- Submission: K011693
- Applicant / Sponsor: Trumpf Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2001-06-13
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.