FDA product code FGX: Snare, Non-Electrical
FGX is the FDA product code for snare, non-electrical. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under FGX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 47 recalls for FGX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Snare, Non-Electrical |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FGX devices
47 product recalls in 4 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-10-24.
| Year | Recalls |
|---|---|
| 2021 | 40 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code FGX?
FGX is the FDA product code for snare, non-electrical. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FGX?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
Have FGX devices been recalled?
Yes: 47 product recalls across 4 recall events; the most recent began 2022-10-24.
Next steps
- Run an FDA pathway report with predicate devices for product code FGX
- Run a recall and safety report across every FGX manufacturer
- Watch product code FGX 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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