OLHClass I

Orchidometer

21 CFR 876.4730 / Gastroenterology, Urology

OLH is the FDA product code for Orchidometer, a class I device type, regulated under 21 CFR 876.4730. FDA's definition for this code reads: "To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OLH
Device name: Orchidometer
FDA definition: To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.
Regulation: 21 CFR 876.4730
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Accurate Surgical & Scientific Instruments Corp.

Recent clearances

Product code OLH

FDA records hold no clearances under product code OLH.

Recent recalls

Product code OLH

FDA records show no recalls under product code OLH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)