Clearance Summary
SURGICAL INSTRUMENT GUIDE received FDA 510(k) clearance under submission number K950007, sponsored by United States Surgical, A Division of Tyco Healthc. 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 1995-03-15.
- Submission: K950007
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1995-03-15
Classification & Regulation
This clearance is catalogued under FDA product code GDF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.