Clearance Summary
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP received FDA 510(k) clearance under submission number K993424, sponsored by Y-Clip Associates. 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 1999-12-23.
- Submission: K993424
- Applicant / Sponsor: Y-Clip Associates
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 1999-12-23
Classification & Regulation
This clearance is catalogued under FDA product code FZP and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.