Clearance Summary
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP received FDA 510(k) clearance under submission number K862696, sponsored by Downs Surgical , Ltd.. 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 1986-07-30.
- Submission: K862696
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-07-30
Classification & Regulation
This clearance is catalogued under FDA product code HBT and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.