510(k) Report

510(k) · Cleared

Cleared

Disposable Overtube

K040836510(k) TraditionalCleared Jun 10, 200471-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

United States Endoscopy Group, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology

Cleared on Jun 10, 2004 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 37 later devices descend from it.

Decided
Jun 10, 2004
Review
71 days
Class
Class II
Product code
FED
Recalls
None
Predicates
0

37 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2008: 4 descendants cleared2009: 3 descendants cleared2006: 2 descendants cleared2010: 1 descendant cleared2005: 1 descendant cleared2012: 4 descendants cleared2019: 2 descendants cleared2007: 1 descendant cleared2016: 3 descendants cleared2013: 1 descendant cleared2011: 1 descendant cleared2020: 2 descendants cleared2015: 1 descendant cleared2018: 3 descendants cleared2023: 2 descendants cleared2021: 2 descendants cleared2026: 1 descendant cleared2014: 1 descendant cleared2024: 2 descendants cleared200020052010201520202025
  1. This deviceK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
  2. Descendant · cites it directly · 18 of its ownK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
  3. Descendant · 2 generations on · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
  4. Descendant · cites it directly · 7 of its ownK063654 EndoguideKms Medical, LLC · 2007
  5. Descendant · 2 generations on · 6 of its ownK191415 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2019
  6. Descendant · 3 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 12008: 42009: 32010: 12011: 12012: 42013: 12014: 12015: 12016: 32018: 32019: 22020: 22021: 22023: 22024: 22026: 1
2005high 4 (2008) · low 0 (2017)2026

Most influential descendants

Showing 5 of 37 · See all
  • K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005 · cites it directly18descendants
  • K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · 2 generations on7descendants
  • K063654EndoguideKms Medical, LLC · 2007 · cites it directly7descendants
  • K191415Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2019 · 2 generations on6descendants
  • K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040836Disposable OvertubeUnited States Endoscopy Group, Inc.2004—
+1K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.2005—
+2K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.2009—
+1K063654EndoguideKms Medical, LLC2007—
+2K191415Pathfinder Endoscope OvertubeNeptune Medical, Inc.2019—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200710
200840
200930
201010
201110
201240
201310
201410
201510
201630
201830
201920
202020
202120
202320
202420
202610
FIG. 1 — Lineage of K040836, 2004–2026Source: 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 FED? 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 FED device

  1. #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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? (37)

See all 37

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.200518
K063654EndoguideKms Medical, LLC20077
K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc.20095
K060235Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.20065
K080550Megachannel Endoscopic Overtube, Model OT22Minos Medical20084
K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc.20103
K082589Barosense Endogastric Tube (Egt), Model F0034Barosense, Inc.20091
K182520Flexible OvertubeSumitomo Bakelite Co., Ltd.20190
K122270Overtube Endoscopic Access SystemApollo Endosurgery, Inc.20120
K073484Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model…Ethicon Endo-Surgery, Inc.20080

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, K052084 (Spirus Medical, Inc., 2005) has gone furthest, with 18 descendants of its own.

How does its category compare?

All FED devices

FED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FED

11in 2025

2007: 12008: 12009: 42010: 32011: 12012: 42013: 22014: 42015: 22016: 52017: 12018: 42019: 52020: 42021: 32022: 12023: 32024: 62025: 112026 (partial year): 6
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FED

120in 2025

2009: 90 days median2010: 90 days median2012: 82 days median2014: 123 days median2016: 126 days median2018: 122 days median2019: 94 days median2020: 117 days median2021: 189 days median2023: 138 days median2024: 98 days median2025: 120 days median2026 (partial year): 67 days median
2007high 189 (2021) · low 82 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FED

4in 2024

2007: 12013: 32024: 4, 4 Class I
2007high 4 (2024) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · FED

115in 2025

2007: 142008: 182009: 192010: 192011: 202012: 352013: 252014: 342015: 352016: 292017: 322018: 342019: 302020: 332021: 552022: 362023: 532024: 642025: 115
2007high 115 (2025) · low 14 (2007)2025

MAUDE reports naming product code FED, 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
20071—114
20081—018
2009490019
2010390019
20111—020
2012482035
20132—325
20144123034
20152—035
20165126029
20171—032
20184122034
2019594030
20204117033
20213189055
20221—036
20233138053
20246984 (4)64
2025111200115
20266670—

What is it indicated for?

The disposable Overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval and/or for endoscopic procedures requiring multiple endoscope intubations.

Indications for use as stated in the FDA 510(k) statement.

More from United States Endoscopy Group, Inc.

94 FDA decisions under this applicant name. See the company

  • K192265gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc. · 20201 recall
  • K200745Lariat, Hot/Cold SnareUnited States Endoscopy Group, Inc. · 2020
  • K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc. · 2019
  • K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc. · 2019
  • K182909Roth Net Retriever Product LineUnited States Endoscopy Group, Inc. · 2018

Recent decisions in FED

The FED category page

  • K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
  • K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
  • K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
  • K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
  • K260965CVAC Aspiration SystemCalyxo, Inc. · 2026

https://510kreport.com/device/K040836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040836: Disposable Overtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040836

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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