FDA product code QCW: Corneal Storage Media With Preservatives Including Anti-Fungal
QCW is the FDA product code for corneal storage media with preservatives including anti-fungal. It is a Class II device, regulated under 21 CFR 886.4320 and reviewed by the Ophthalmic panel. Devices under QCW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Media to preserve human corneas while in storage.
Classification
| Field | Value |
|---|---|
| Device name | Corneal Storage Media With Preservatives Including Anti-Fungal |
| Device class | Class II |
| Regulation | 21 CFR 886.4320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for QCW devices
openFDA lists no recalls for product code QCW.
Frequently asked questions
What is FDA product code QCW?
QCW is the FDA product code for corneal storage media with preservatives including anti-fungal. It is a Class II device, regulated under 21 CFR 886.4320 and reviewed by the Ophthalmic panel.
What device class is QCW?
Class II, regulation 21 CFR 886.4320. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QCW
- Run a recall and safety report across every QCW manufacturer
- Watch product code QCW 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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