Product code QYK— General, Plastic Surgery
Medline ART Skin Harvesting System
- Classification name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Device class
- Class 2
- Regulation
- 21 CFR 878.4795
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QYK
FDA has cleared device under product code QYK, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QYK
Recent clearances under product code QYK
Data sourced from openFDA. This site is unofficial and independent of the FDA.