FDA applicant

G.U.-Tek

South Plainfield, NJ1 decision2001–20010 recalls

FDA records 1 decision for G.U.-Tek (South Plainfield, NJ) in 2001: 1 510(k) clearance. All are in product code LJH (System, Irrigation, Urological). 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 G.U.-Tek’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for G.U.-Tek since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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G.U.-Tek

Which product codes does it file in?

What has FDA decided for it lately?