DEN210049 is an FDA 510(k) submission for the Medline ART Skin Harvesting System. This device is classified as a Semi-automated Autologous Skin Graft Harvesting And Application Device (Class II - Special Controls, product code QYK).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Not Cleared (DENG) decision on March 27, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4795. 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..
| 510(k) Number | DEN210049 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 19, 2021 |
| Decision Date | March 27, 2024 |
| Days to Decision | 890 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | QYK — Semi-automated Autologous Skin Graft Harvesting And Application Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4795 |
| 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. |