FDA product code MOA: Analyzer, Diagnostic, Fiber Optic (Colon)
MOA is the FDA product code for analyzer, diagnostic, fiber optic (colon). It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MOA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Diagnostic, Fiber Optic (Colon) |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MOA devices
openFDA lists no recalls for product code MOA.
Frequently asked questions
What is FDA product code MOA?
MOA is the FDA product code for analyzer, diagnostic, fiber optic (colon). It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MOA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MOA
- Run a recall and safety report across every MOA manufacturer
- Watch product code MOA 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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