FDA product code EXH: Bag, Urinary, Ileostomy
EXH is the FDA product code for bag, urinary, ileostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. Devices under EXH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Urinary, Ileostomy |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for EXH devices
openFDA lists no recalls for product code EXH.
Frequently asked questions
What is FDA product code EXH?
EXH is the FDA product code for bag, urinary, ileostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EXH?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EXH
- Run a recall and safety report across every EXH manufacturer
- Watch product code EXH 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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