Clearance Summary
DynaMesh-VENTRAL received FDA 510(k) clearance under submission number K161550, sponsored by Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft. 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 2016-12-22.
- Submission: K161550
- Applicant / Sponsor: Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2016-12-22
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.