Clearance Summary
SUTURE CLIP APPLIER/REMOVER received FDA 510(k) clearance under submission number K890233, sponsored by Kinetic Medical Products. 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 1989-01-27.
- Submission: K890233
- Applicant / Sponsor: Kinetic Medical Products
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1989-01-27
Classification & Regulation
This clearance is catalogued under FDA product code GDO and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.