FDA product code QWY: Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
QWY is the FDA product code for mechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator. It is a Class III device, reviewed by the Hematology panel. Devices under QWY reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Intended for use at the patients point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo.
Classification
| Field | Value |
|---|---|
| Device name | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QWY devices
openFDA lists no recalls for product code QWY.
Frequently asked questions
What is FDA product code QWY?
QWY is the FDA product code for mechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator. It is a Class III device, reviewed by the Hematology panel.
What device class is QWY?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QWY
- Run a recall and safety report across every QWY manufacturer
- Watch product code QWY 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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