Clearance Summary
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL received FDA 510(k) clearance under submission number K153076, sponsored by Teleflexmedical, 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 2016-06-16.
- Submission: K153076
- Applicant / Sponsor: Teleflexmedical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2016-06-16
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.