Clearance Summary
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE received FDA 510(k) clearance under submission number K131224, sponsored by Surgical Specialties Corp. Dba Angiotech. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2013-05-16.
- Submission: K131224
- Applicant / Sponsor: Surgical Specialties Corp. Dba Angiotech
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5010
- Decision date: 2013-05-16
Classification & Regulation
This clearance is catalogued under FDA product code GAW and 21 CFR 878.5010, within the General, Plastic Surgery review panel as a Class II device.