510(k) K162461
K162461 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery (Formerly Mesynthes Limited) for the device "Endoform Plastics and Reconstructive Matrix". The FDA issued a decision of Substantially Equivalent on Dec 20, 2016. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2016
- Date Received
- Sep 2, 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
- 510(k)