FDA product code FGN: Retractor, Non-Self-Retaining
FGN is the FDA product code for retractor, non-self-retaining. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under FGN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Retractor, Non-Self-Retaining |
| 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 FGN devices
openFDA lists no recalls for product code FGN.
Frequently asked questions
What is FDA product code FGN?
FGN is the FDA product code for retractor, non-self-retaining. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FGN?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FGN
- Run a recall and safety report across every FGN manufacturer
- Watch product code FGN 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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