QYK · Semi-Automated Autologous Skin Graft Harvesting And Application Device
General, Plastic Surgery · 21 CFR 878.4795 · Class 2
Overview
| Product Code | QYK |
|---|---|
| Device Name | Semi-Automated Autologous Skin Graft Harvesting And Application Device |
| Regulation | 21 CFR 878.4795 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Medline Industries, Inc. | Mar 27, 2024 | DENG |
Top Applicants
- Medline Industries, Inc. — 1 clearance
