OLH — Orchidometer Class I
FDA product code OLH covers "Orchidometer", a Class I medical device regulated under 21 CFR 876.4730. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- OLH
- Device Class
- Class I
- Regulation Number
- 876.4730
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.