QYK

Semi-Automated Autologous Skin Graft Harvesting And Application Device

Product code

QYK

Device name

Semi-Automated Autologous Skin Graft Harvesting And Application Device

Device class

Class 2

21 CFR

21 CFR 878.4795

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-03-27.