← FDA Medical Device Classifications
Orchidometer
OLH · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.4730
Classification
- FDA Product Code
OLH- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 876.4730
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown