Clearance Summary
NEATSTITCH NEATCLOSE SUTURING DEVICE received FDA 510(k) clearance under submission number K063462, sponsored by Neat Stitch , 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 2007-01-12.
- Submission: K063462
- Applicant / Sponsor: Neat Stitch , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2007-01-12
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.