FDA applicant

General Polymers

Great Neck, NY1 decision1997–19970 recalls

FDA records 1 decision for General Polymers (Great Neck, NY) in 1997: 1 510(k) clearance. All are in product code EXJ (Device, Incontinence, Urosheath Type, Sterile). 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 General Polymers’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Polymers since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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General Polymers

Which product codes does it file in?

What has FDA decided for it lately?