Clearance Summary
Nexo-Gide Bilayer Collagen Membrane received FDA 510(k) clearance under submission number K203496, sponsored by Geistlich Pharma AG. 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 2021-07-14.
- Submission: K203496
- Applicant / Sponsor: Geistlich Pharma AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2021-07-14
Classification & Regulation
This clearance is catalogued under FDA product code FTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.