FDA product code FDW: Esophagoscope, Rigid, Gastro-Urology
FDW is the FDA product code for esophagoscope, rigid, gastro-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under FDW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Esophagoscope, Rigid, Gastro-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for FDW devices
openFDA lists no recalls for product code FDW.
Frequently asked questions
What is FDA product code FDW?
FDW is the FDA product code for esophagoscope, rigid, gastro-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDW?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FDW
- Run a recall and safety report across every FDW manufacturer
- Watch product code FDW 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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