Clearance Summary
DYNAMESH -CICAT received FDA 510(k) clearance under submission number K131530, sponsored by Feg Textiltechnik Forschungs-Und Entwicklungsgesel. 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 2013-10-23.
- Submission: K131530
- Applicant / Sponsor: Feg Textiltechnik Forschungs-Und Entwicklungsgesel
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2013-10-23
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.