510(k) Report

FDA applicant

Marks & Murase

New York, NY3 decisions1994–19952 recalls

FDA records 3 decisions for Marks & Murase (New York, NY) from 1994 to 1995: 3 510(k) clearances. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and EOB (Nasopharyngoscope (Flexible Or Rigid)). 2 recalls are 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 Marks & Murase’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marks & Murase since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2decisions
  • EOBNasopharyngoscope (Flexible Or Rigid)1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K944620Series 400 Gastroenterology SystemMarks & Murase · 19955cite it

What has FDA decided for it lately?

  • K950417Epx-310 Video Processor (Endoscopy)Marks & Murase · 1995
  • K944620Series 400 Gastroenterology SystemMarks & Murase · 19952 recalls
  • K934422NasopharyngoscopeMarks & Murase · 1994

All 3 as Marks & Murase →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K042076Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5…Jun 30, 2015Class II
  • K041903Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower…Mar 27, 2006