FDA applicant

Cogentix Medical, Inc.

Orangeburg, NY2 decisions2018–20260 recalls

FDA records 2 decisions for Cogentix Medical, Inc. (Orangeburg, NY) from 2018 to 2026: 2 510(k) clearances. Most are in product codes EOX (Esophagoscope (Flexible Or Rigid)) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Its devices cite 5 predicates, 0 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, ear, nose and throat panel, where it files most

How often FDA has decided Cogentix Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Cogentix Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cogentix Medical, 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

Cogentix Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?