510(k) DEN210049
DEN210049 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline ART Skin Harvesting System". The FDA issued a decision of De Novo Granted on March 27, 2024. The device falls under product code QYK (Semi-Automated Autologous Skin Graft Harvesting And Application Device), a Class II device regulated under 21 CFR 878.4795. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 27, 2024
- Date Received
- October 19, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Device Class
- Class II
- Regulation Number
- 878.4795
- Review Panel
- SU
- Submission Type
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.