Clearance Summary
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR received FDA 510(k) clearance under submission number K013718, sponsored by Gynecare, A Div. of Ethicon, Inc.. 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 2002-01-08.
- Submission: K013718
- Applicant / Sponsor: Gynecare, A Div. of Ethicon, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2002-01-08
Classification & Regulation
This clearance is catalogued under FDA product code OTO and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.