510(k) Report

510(k) · Cleared

Cleared

Endo-Ease Endoscopic Overtube

K060235510(k) TraditionalCleared Aug 4, 2006186-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

Spirus Medical, Inc. · FDA Enteroscope And Accessories

Cleared on Aug 4, 2006 as substantially equivalent to K052084 (Spirus Medical, Inc., 2005) and 3 other predicates after a 186-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.

Decided
Aug 4, 2006
Review
186 days
Class
Class II
Product code
FDA
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K993704 (2000). 5 ancestors in all, the oldest K973500 (1997). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1997: 1 other ancestor2008: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2020: 1 descendant cleared2015: 1 descendant clearedK993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 2000K040048 · Fujinon Double Balloon Enteroscopy System · Fujinon, Inc. · 2004K052084 · Endo-Ease Endoscopic Overtube · Spirus Medical, Inc. · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant K052084 · Endo-Ease Endoscopic Overtube · Spirus Medical, Inc. · 2005K040048 · Fujinon Double Balloon Enteroscopy System · Fujinon, Inc. · 2004K993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 20000
  1. Root · 3 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
  2. 2 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
  3. 1 generation backK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
  4. This deviceK060235 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006
  5. Descendant · cites it directly · 4 of its ownK080050 Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008
  6. Descendant · 2 generations on · 3 of its ownK100081 Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010
  7. Descendant · 3 generations on · 1 of its ownK110531 Endoflip EcdCrospon, Ltd. · 2011
  8. Descendant · 3 generations on · 0 of its ownK192691 PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020
  9. Descendant · 4 generations on · 0 of its ownK150083 Sidecar External Working ChannelC2 Therapeutics · 2015

Most influential descendants

Showing 5 of 5 · See all
  • K080050Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008 · cites it directly4descendants
  • K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010 · 2 generations on3descendants
  • K110531Endoflip EcdCrospon, Ltd. · 2011 · 3 generations on1descendant
  • K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020 · 3 generations on0descendants
  • K150083Sidecar External Working ChannelC2 Therapeutics · 2015 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993704Gastro-Intestinal System EN-410WMFujinon, Inc.2000—
−2K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc.2004—
−1K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.2005—
0 (this device)K060235Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.2006—
+1K080050Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.2008—
+2K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc.2010—
+3K110531Endoflip EcdCrospon, Ltd.2011—
+3K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc.2020—
+4K150083Sidecar External Working ChannelC2 Therapeutics2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201110
201510
202010
FIG. 1 — Lineage of K060235, 2000–2020Source: 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 summary (predicates and 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? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K052084Endo-Ease Endoscopic Overtube
Summary page 1
…ation: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K052084 - Spirus Medical Endo-Ease Overtube K040048 - Balloon Overtube (Fujinon Corp.) K973…
Spirus Medical, Inc.2005—
*K040048Fujinon Double Balloon Enteroscopy System
Summary page 1
…nd Cosmetic Act, the device classification is Class II. Predicate Devices: K052084 - Spirus Medical Endo-Ease Overtube K040048 - Balloon Overtube (Fujinon Corp.) K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.)…
Fujinon, Inc.2004—
*K973500Bard Endoscopic Overtube (#000307)
Summary page 1
…is Class II. Predicate Devices: K052084 - Spirus Medical Endo-Ease Overtube K040048 - Balloon Overtube (Fujinon Corp.) K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.) K040836 - Disposable Overtube (U.S. Endoscopy) Product Descr…
C.R. Bard, Inc.1997—
*K040836Disposable Overtube
Summary page 1
…tube K040048 - Balloon Overtube (Fujinon Corp.) K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.) K040836 - Disposable Overtube (U.S. Endoscopy) Product Description: The device described in this 510(k) consists of a sterile, single us…
United States Endoscopy Group, Inc.2004—

Also cleared against K052084: 3 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K080050Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.20084

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?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K080050 (Spirus Medical, Inc., 2008) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K052084.

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?

The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

Indications for use as stated in the FDA summary.

Also cleared against K052084

3 other devices cite the same predicate.

  • K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc. · 2009
  • K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
  • K062805Modification to Endo-EaseSpirus Medical, Inc. · 2006

More from Spirus Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K080050Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008
  • K080042Spirus Medical Surgical InstrumentSpirus Medical, Inc. · 2008
  • K062805Modification to Endo-EaseSpirus Medical, Inc. · 2006
  • K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005

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/K060235 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060235: Endo-Ease Endoscopic Overtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060235

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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