FDA product code GMW: Test, Sorbent, Fta-Abs
GMW is the FDA product code for test, sorbent, fta-abs. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. Devices under GMW reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for GMW devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Sorbent, Fta-Abs |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GMW devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-01-21.
Frequently asked questions
What is FDA product code GMW?
GMW is the FDA product code for test, sorbent, fta-abs. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is GMW?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
Have GMW devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2005-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GMW
- Run a recall and safety report across every GMW manufacturer
- Watch product code GMW 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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