Definition: Intended To Enable Clinicians To Prepare An Autologous Skin Cell Suspension For Application To Burn Injuries For Use When Autografting Is Indicated For Definitive Wound Closure.
| Device Type ID | 2513 |
| Device Name | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator |
| Physical State | The Cell Harvesting Device Is Comprised Of A Bundled Set Of Prep Instruments, Application Tools, Processing And Carrier Solutions Packaged As A Single, Sterile, Stand-alone, Disposable (single-use Kit). The Device May Include: (1) A Processing Unit F |
| Technical Method | Processing Of A Split-thickness Skin Sample Using Enzymatic And Mechanical Disaggregation To Create A Cell Suspension. |
| Target Area | The Device Output Cell Suspension Is Applied To A Burn Injury Wound Bed And Skin Donor Site That Have Been Prepared By A Healthcare Provider To Receive Application Of A Skin Autograft. |
| Review Panel | Hematology |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QCZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |