FDA product code EXX: Probe, Rectal, Non-Powered
EXX is the FDA product code for probe, rectal, non-powered. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under EXX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for EXX devices.
Classification
| Field | Value |
|---|---|
| Device name | Probe, Rectal, Non-Powered |
| 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 EXX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-09.
Frequently asked questions
What is FDA product code EXX?
EXX is the FDA product code for probe, rectal, non-powered. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is EXX?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
Have EXX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EXX
- Run a recall and safety report across every EXX manufacturer
- Watch product code EXX 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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