510(k) · Cleared
ClearedEnteroscopy Overtube, Model 00712140
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Apr 12, 2010 as substantially equivalent to K040836 (United States Endoscopy Group, Inc., 2004) and 3 other predicates after a 90-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Apr 12, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K993704 (2000). 13 ancestors in all, the oldest K853585 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 4 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 3 generations backK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
- 2 generations backK060235 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006
- 1 generation backK080050 Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008
- This deviceK100081 Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK110531 Endoflip EcdCrospon, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK192691 PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK150083 Sidecar External Working ChannelC2 Therapeutics · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −4 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −3 | K052084 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2005 | — |
| −2 | K060235 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2006 | — |
| −1 | K080050 | Spirus Medical Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2008 | — |
| 0 (this device) | K100081 | Enteroscopy Overtube, Model 00712140 | United States Endoscopy Group, Inc. | 2010 | — |
| +1 | K110531 | Endoflip Ecd | Crospon, Ltd. | 2011 | — |
| +1 | K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020 | — |
| +2 | K150083 | Sidecar External Working Channel | C2 Therapeutics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
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 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 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040836 | Disposable OvertubeSummary page 1…s II, per 21 CFR 876.1500 Product Code: 78 (FED) Predicate Device Disposable Overtube (Guardus® overtube disposable) 510(k) 040836 Endo-Ease Endoscopic Overtube 510(k) 080050 St-El Overtube… | 2004 |
| * | K080050 | Spirus Medical Endo-Ease Endoscopic OvertubeSummary page 1…Predicate Device Disposable Overtube (Guardus® overtube disposable) 510(k) 040836 Endo-Ease Endoscopic Overtube 510(k) 080050 St-El Overtube 510(k) 903842 Colonic Splinting Overtube… | 2008 |
| * | K903842 | ST-E1 OvertubeSummary page 1…510(k) 040836 Endo-Ease Endoscopic Overtube 510(k) 080050 St-El Overtube 510(k) 903842 Colonic Splinting Overtube 5 10(k) 092221 Description of Device The device is an endoscop… | 1991 |
| * | K092221 | Colonic Splinting Overtube, Model 00711145Summary page 1…510(k) 080050 St-El Overtube 510(k) 903842 Colonic Splinting Overtube 5 10(k) 092221 Description of Device The device is an endoscopic accessory designed to provide external support to and maintain a path for an… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K110531 (Crospon, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K040836.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100081 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100081: Enteroscopy Overtube, Model 00712140.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100081
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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