FDA product code QYK

Semi-Automated Autologous Skin Graft Harvesting And Application Device

General, Plastic Surgery·Class 2·21 CFR 878.4795
US regulatory classifications
US Product Code (FDA)
QYK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4795
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Semi-Automated Autologous Skin Graft Harvesting And Application Device is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.