510(k) K162570
K162570 is an FDA 510(k) premarket notification submitted by Miromatrix Medical, Inc. for the device "Miromatrix Biological Mesh TW". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Miromatrix Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2017
- Date Received
- September 15, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type