FDA product code OLH: Orchidometer
OLH is the FDA product code for orchidometer. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under OLH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.
Classification
| Field | Value |
|---|---|
| Device name | Orchidometer |
| 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 OLH devices
openFDA lists no recalls for product code OLH.
Frequently asked questions
What is FDA product code OLH?
OLH is the FDA product code for orchidometer. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is OLH?
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 OLH
- Run a recall and safety report across every OLH manufacturer
- Watch product code OLH 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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