QYK · Class II · 21 CFR 878.4795

FDA Product Code QYK: Semi-automated Autologous Skin Graft Harvesting And Application Device

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.

Leading manufacturers include Medline Industries, Inc..

1
Total
0
Cleared
890d
Avg days
2024
Since

List of Semi-automated Autologous Skin Graft Harvesting And Application Device devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Semi-automated Autologous Skin Graft Harvesting And Application Device devices (product code QYK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →