Clearance Summary
DuraGraft received FDA 510(k) clearance under submission number DEN230002, sponsored by Marizyme, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-10-04.
- Submission: DEN230002
- Applicant / Sponsor: Marizyme, Inc.
- Clearance pathway: Direct
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4100
- Decision date: 2023-10-04
Classification & Regulation
This clearance is catalogued under FDA product code QEJ and 21 CFR 876.4100, within the Gastroenterology, Urology review panel as a Class II device.