Clearance Summary
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM received FDA 510(k) clearance under submission number K911158, sponsored by Northgate Technologies, 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 1991-03-29.
- Submission: K911158
- Applicant / Sponsor: Northgate Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1991-03-29
Classification & Regulation
This clearance is catalogued under FDA product code LRW and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.