510(k) Report

FDA applicant

Widran Urological Group, Ltd.

Walker, MI2 decisions1982–19860 recalls

FDA records 2 decisions for Widran Urological Group, Ltd. (Walker, MI) from 1982 to 1986: 2 510(k) clearances. Most are in product codes LJH (System, Irrigation, Urological) and LJK (Antisera, If, Toxoplasma Gondii). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Widran Urological Group, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Widran Urological Group, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Widran Urological Group, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report