510(k) · Cleared
ClearedEndo-Ease Endoscopic Overtube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirus Medical, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 14, 2005 as substantially equivalent to K040048 (Fujinon, Inc., 2004) and 2 other predicates after a 43-day review. Its family tree reaches back 2 generations to 2000. 18 later devices descend from it.
- Decided
- Sep 14, 2005
- Review
- 43 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K993704 (2000). 4 ancestors in all, the oldest K973500 (1997). 18 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 1 generation backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- This deviceK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 3 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · cites it directly · 5 of its ownK092221 Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK060235 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · cites it directly7descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on5descendants
- K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc. · 2009 · cites it directly5descendants
- K060235Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −1 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| 0 (this device) | K052084 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2005 | — |
| +1 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| +2 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +3 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +1 | K092221 | Colonic Splinting Overtube, Model 00711145 | United States Endoscopy Group, Inc. | 2009 | — |
| +1 | K060235 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K040048 | Fujinon Double Balloon Enteroscopy SystemSummary page 1…ation: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K040048 - Balloon Overtube (Fujinon Corp.) K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.)… | 2004 |
| * | K973500 | Bard Endoscopic Overtube (#000307)Summary page 1…and Cosmetic Act, the device classification is Class II. Predicate Devices: K040048 - Balloon Overtube (Fujinon Corp.) K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.) K040836 - Disposable Overtube (U.S. Endoscopy) Product Desc… | 1997 |
| * | K040836 | Disposable OvertubeSummary page 1…II. Predicate Devices: 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 u… | 2004 |
What descends from it? (18)
See all 184 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 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092156 (Softscope Medical Technologies, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K040048.
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.
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 Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052084: Endo-Ease Endoscopic Overtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052084
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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