Clearance Summary
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE received FDA 510(k) clearance under submission number K883858, sponsored by Advanced Surgical Products, 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 1988-09-29.
- Submission: K883858
- Applicant / Sponsor: Advanced Surgical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1988-09-29
Classification & Regulation
This clearance is catalogued under FDA product code HBI and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.