FDA product code EXS: Urinometer, Electrical
EXS is the FDA product code for urinometer, electrical. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel. Devices under EXS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 6 recalls for EXS devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Urinometer, Electrical |
| Device class | Class II |
| Regulation | 21 CFR 876.1800 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for EXS devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-11-15.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code EXS?
EXS is the FDA product code for urinometer, electrical. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel.
What device class is EXS?
Class II, regulation 21 CFR 876.1800. Typical premarket route: 510(k) exempt.
Have EXS devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2023-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code EXS
- Run a recall and safety report across every EXS manufacturer
- Watch product code EXS 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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