510(k) K153633
K153633 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery Limited (Formerly Mesynthes Limited) for the device "Endoform Reconstructive Template". The FDA issued a decision of Substantially Equivalent on Mar 15, 2016. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Aroa Biosurgery Limited (Formerly Mesynthes Limited) has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 2016
- Date Received
- Dec 18, 2015
- Clearance Type
- Special
- 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)