QYK — Semi-Automated Autologous Skin Graft Harvesting And Application Device Class II
FDA product code QYK covers "Semi-Automated Autologous Skin Graft Harvesting And Application Device", a Class II medical device regulated under 21 CFR 878.4795. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QYK
- Device Class
- Class II
- Regulation Number
- 878.4795
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210049 | medline industries | Medline ART Skin Harvesting System | March 27, 2024 |