Clearance Summary
S&T MICROSURGICAL SUTURE received FDA 510(k) clearance under submission number K031531, sponsored by S & T AG. 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 2003-09-23.
- Submission: K031531
- Applicant / Sponsor: S & T AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5020
- Decision date: 2003-09-23
Classification & Regulation
This clearance is catalogued under FDA product code GAR and 21 CFR 878.5020, within the General, Plastic Surgery review panel as a Class II device.