Clearance Summary
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) received FDA 510(k) clearance under submission number K173796, sponsored by Sofradim Production. 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 2018-03-09.
- Submission: K173796
- Applicant / Sponsor: Sofradim Production
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2018-03-09
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.