Clearance Summary
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE received FDA 510(k) clearance under submission number K052373, sponsored by Quill Medical, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-09-26.
- Submission: K052373
- Applicant / Sponsor: Quill Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5010
- Decision date: 2005-09-26
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.