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
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Semi-automated Autologous Skin Graft Harvesting And Application Device Devices (Product Code QYK)
1 devices
About Product Code QYK - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QYK since 2024, with 0 receiving FDA clearance (average review time: 890 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.