FDA product code EXG: Bag, Urine Collecting, Ureterostomy
EXG is the FDA product code for bag, urine collecting, ureterostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. Devices under EXG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for EXG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Urine Collecting, Ureterostomy |
| 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 EXG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-06.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code EXG?
EXG is the FDA product code for bag, urine collecting, ureterostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EXG?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
Have EXG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-07-06.
Next steps
- Run an FDA pathway report with predicate devices for product code EXG
- Run a recall and safety report across every EXG manufacturer
- Watch product code EXG 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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