510(k) Report

510(k) · Cleared

Cleared

Gastro-Intestinal System EN-410WM

K993704510(k) TraditionalCleared Feb 11, 2000101-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujinon, Inc. · FDA Enteroscope And Accessories

Cleared on Feb 11, 2000 after a 101-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 65 later devices descend from it.

Decided
Feb 11, 2000
Review
101 days
Class
Class II
Product code
FDA
Recalls
None
Predicates
0

65 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 2 descendants cleared2009: 5 descendants cleared2006: 3 descendants cleared2011: 3 descendants cleared2015: 3 descendants cleared2012: 4 descendants cleared2019: 4 descendants cleared2008: 3 descendants cleared2016: 5 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2021: 4 descendants cleared2017: 1 descendant cleared2023: 4 descendants cleared2024: 4 descendants cleared2013: 2 descendants cleared2020: 2 descendants cleared2026: 5 descendants cleared2018: 2 descendants cleared2022: 1 descendant cleared2025: 3 descendants cleared200020052010201520202025
  1. This deviceK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
  2. Descendant · cites it directly · 64 of its ownK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
  3. Descendant · 2 generations on · 45 of its ownK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
  4. Descendant · 2 generations on · 19 of its ownK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
  5. Descendant · 2 generations on · 18 of its ownK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
  6. Descendant · 3 generations on · 8 of its ownK162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 32008: 32009: 52010: 22011: 32012: 42013: 22014: 22015: 32016: 52017: 12018: 22019: 42020: 22021: 42022: 12023: 42024: 42025: 32026: 5
2004high 5 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 65 · See all
  • K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004 · cites it directly64descendants
  • K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc. · 2009 · 2 generations on45descendants
  • K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015 · 2 generations on19descendants
  • K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005 · 2 generations on18descendants
  • K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993704Gastro-Intestinal System EN-410WMFujinon, Inc.2000—
+1K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc.2004—
+2K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.2009—
+2K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.2015—
+2K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.2005—
+3K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200630
200830
200950
201020
201130
201240
201320
201420
201530
201650
201710
201820
201940
202020
202140
202210
202340
202440
202530
202650
FIG. 1 — Lineage of K993704, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FDA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FDA device

  1. #1 K260314 Ancora-SBscore 13.4 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (65)

See all 65

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc.200464

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040048 (Fujinon, Inc., 2004) has gone furthest, with 64 descendants of its own.

How does its category compare?

All FDA devices

FDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDA

1in 2025

2008: 12015: 12019: 22020: 12021: 12023: 22024: 12025: 12026 (partial year): 1
2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDA

Too few FDA 510(k)s in any year since 2007 to give a median.

Recalls per year · FDA

No recall names FDA since 2007.

Adverse event reports per year · FDA

116in 2025

2007: 12008: 12009: 32010: 12012: 22013: 22014: 32015: 22016: 52017: 282018: 812019: 762020: 292021: 242022: 872023: 722024: 862025: 116
2007high 116 (2025) · low 0 (2011)2025

MAUDE reports naming product code FDA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20081—01
20090—03
20100—01
20110—00
20120—02
20130—02
20140—03
20151—02
20160—05
20170—028
20180—081
20192—076
20201—029
20211—024
20220—087
20232—072
20241—086
20251—0116
20261—0—

What is it indicated for?

This video enteroscope is for the optical visualization of the upper gastrointestinal tract. This includes the Esophagus, Stomach, Duodeum and Small Bowel. It is intended for observation, diagnosis and endoscopic treatment.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Fujinon, Inc.

30 FDA decisions under this applicant name. See the company

  • K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 20121 recall
  • K112391Fujinon ColonoscopesFujinon, Inc. · 2012
  • K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
  • K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
  • K091773Fujinon Sterile OvertubesFujinon, Inc. · 2009

Recent decisions in FDA

The FDA category page

  • K260314Ancora-SBAspero Medical, Inc. · 2026
  • K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
  • K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
  • K231323Ancora-SBAspero Medical, Inc. · 2023
  • K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton · 2023

https://510kreport.com/device/K993704 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993704: Gastro-Intestinal System EN-410WM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993704

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026