510(k) DEN210049
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 27, 2024
- Date Received
- October 19, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Device Class
- Class II
- Regulation Number
- 878.4795
- Review Panel
- SU
- Submission Type
A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns.