QYK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4795
- Medical specialty
- General, Plastic Surgery
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Medline ART Skin Harvesting System (DEN210049) | Medline Industries, Inc. | 2024-03-27 |
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