510(k) Report

FDA applicant

Eris Medical Technology

New Providence, NJ3 decisions1985–19880 recalls

FDA records 3 decisions for Eris Medical Technology (New Providence, NJ) from 1985 to 1988: 3 510(k) clearances. Most are in product codes FFG (Device, Urine Flow Rate Measuring…) and 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 Eris Medical Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eris Medical Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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