FDA applicant

Entech, Inc.

Lebanon, NJ7 decisions1986–19890 recalls

FDA records 7 decisions for Entech, Inc. (Lebanon, NJ) from 1986 to 1989: 7 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FRN (Pump, Infusion). 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 Entech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Entech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Entech, Inc.’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

Entech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?