FDA product code · Gastroenterology and urology

Orchidometer

Name: FDA decisions, review times, recalls and adverse event reports for product code OLH
Creator: 510(k) Report

OLHClass I21 CFR 876.4730510(k) exempt0 decisions0 recalls

FDA lists OLH as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of OLH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — OLH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OLH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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Other codes under 21 CFR 876.4730.

KOA Surgical Instruments, G-U, Manual (And…FCH Tray, Biopsy, Without Biopsy Instruments FFR Device, Locking, For Intestinal Clamp PVY Vasovasostomy Set FKK Clamp, Line FFN Clamp, Non-Electrical FHK Spreader, Bladder Neck FHI Ring, Laparotomy FGM Probe And Director, Gastro-Urology FFO Retractor, Self-Retaining OOW Applicator For Rectal Suppository FGX Snare, Non-Electrical