Clearance Summary
PuraStat-RM received FDA 510(k) clearance under submission number K213552, sponsored by 3-D Matrix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2022-04-01.
- Submission: K213552
- Applicant / Sponsor: 3-D Matrix, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2022-04-01
Classification & Regulation
This clearance is catalogued under FDA product code PHN , within the Unknown review panel as a device.