FDA product code QCZ: Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator
QCZ is the FDA product code for mechanical and enzymatic autologous skin processor for cell suspension, with applicator. It is a Class III device, reviewed by the Hematology panel. Devices under QCZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for QCZ devices
openFDA lists no recalls for product code QCZ.
Frequently asked questions
What is FDA product code QCZ?
QCZ is the FDA product code for mechanical and enzymatic autologous skin processor for cell suspension, with applicator. It is a Class III device, reviewed by the Hematology panel.
What device class is QCZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QCZ
- Run a recall and safety report across every QCZ manufacturer
- Watch product code QCZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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