FDA product code QYK: Semi-Automated Autologous Skin Graft Harvesting And Application Device

QYK is the FDA product code for semi-automated autologous skin graft harvesting and application device. It is a Class II device, regulated under 21 CFR 878.4795 and reviewed by the General and Plastic Surgery panel. Devices under QYK reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QYK devices

openFDA lists no recalls for product code QYK.

Frequently asked questions

What is FDA product code QYK?

QYK is the FDA product code for semi-automated autologous skin graft harvesting and application device. It is a Class II device, regulated under 21 CFR 878.4795 and reviewed by the General and Plastic Surgery panel.

What device class is QYK?

Class II, regulation 21 CFR 878.4795. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QYK
• Run a recall and safety report across every QYK manufacturer
• Watch product code QYK for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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