Clearance Summary
WEGO-PGCL Absorbable Surgical Monofilament Suture received FDA 510(k) clearance under submission number K142810, sponsored by Foosin Medical Supplies Inc., Ltd.. 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 2014-11-14.
- Submission: K142810
- Applicant / Sponsor: Foosin Medical Supplies Inc., Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2014-11-14
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.