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U.S. Department of Health and Human Services

Product Classification

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Device mechanical and enzymatic autologous skin processor for cell suspension, with applicator
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.
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 for tissue incubation, rinsing, and filtering; (2) prep instruments: syringe, blunt needle, disposable scalper, spray nozzle, cell strainer; and (3) processing and carrier solutions: enzyme, sterile water, buffer. The cell suspension may be applied using a syringe outfitted with a spray nozzle.
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
Product CodeQCZ
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible