FDA applicant

Ercons, Inc.

New York, NY6 decisions1997–19990 recalls

FDA records 6 decisions for Ercons, Inc. (New York, NY) from 1997 to 1999: 6 510(k) clearances. All are in product code LKY (Device, External Penile Rigidity). Its devices cite 28 predicates, 2 of them its own earlier devices. 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 Ercons, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ercons, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ercons, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?