510(k) Report

FDA applicant

Endolumik

Morgantown, WV2 decisions2023–20240 recalls

FDA records 2 decisions for Endolumik (Morgantown, WV) from 2023 to 2024: 2 510(k) clearances. All are in product code KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Endolumik, Inc.”.

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 Endolumik’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Endolumik by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc. · 20231cites it

What has FDA decided for it lately?

  • K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)Endolumik · 2024
  • K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc. · 2023

The one decision as Endolumik →The one decision as Endolumik, Inc. →