Product code QYK

Device name

Semi-Automated Autologous Skin Graft Harvesting And Application Device

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4795

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset