Clearance Summary
PuraStat received FDA 510(k) clearance under submission number K242250, sponsored by 3-D Matrix Europe SAS. 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 2024-10-22.
- Submission: K242250
- Applicant / Sponsor: 3-D Matrix Europe SAS
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4456
- Decision date: 2024-10-22
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.