Clearance Summary
PuraStat-GI received FDA 510(k) clearance under submission number K210098, sponsored by 3-D Matrix, Inc.. 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 2021-06-25.
- Submission: K210098
- Applicant / Sponsor: 3-D Matrix, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4456
- Decision date: 2021-06-25
Classification & Regulation
This clearance is catalogued under FDA product code QAU and 21 CFR 878.4456, within the General, Plastic Surgery review panel as a Class II device.