510(k) · Cleared
ClearedSpirus Medical Endo-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 May 6, 2008 as substantially equivalent to K060235 (Spirus Medical, Inc., 2006) after a 119-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- May 6, 2008
- Review
- 119 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993704 (2000). 6 ancestors in all, the oldest K973500 (1997). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 3 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 2 generations backK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
- 1 generation backK060235 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006
- This deviceK080050 Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK100081 Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK110531 Endoflip EcdCrospon, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK192691 PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK150083 Sidecar External Working ChannelC2 Therapeutics · 2015
Most influential descendants
Showing 4 of 4 · See all- K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010 · cites it directly3descendants
- K110531Endoflip EcdCrospon, Ltd. · 2011 · 2 generations on1descendant
- K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020 · 2 generations on0descendants
- K150083Sidecar External Working ChannelC2 Therapeutics · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −3 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −2 | K052084 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2005 | — |
| −1 | K060235 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2006 | — |
| 0 (this device) | K080050 | Spirus Medical Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2008 | — |
| +1 | K100081 | Enteroscopy Overtube, Model 00712140 | United States Endoscopy Group, Inc. | 2010 | — |
| +2 | K110531 | Endoflip Ecd | Crospon, Ltd. | 2011 | — |
| +2 | K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020 | — |
| +3 | K150083 | Sidecar External Working Channel | C2 Therapeutics | 2015 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K060235 | Endo-Ease Endoscopic OvertubeSummary page 1…Regulation: 21 CFR 876.1500 - Endoscope & accessories Device Classification: Class II Premarket Notification: K060235 Product Description: The device described in this 510(k) consists of a modified sterile, single use, flexible overtu… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100081 | Enteroscopy Overtube, Model 00712140 | 2010 | 3 |
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 8 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K100081 (United States Endoscopy Group, Inc., 2010) has gone furthest, with 3 descendants of its own.
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. 2008, 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 Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy. 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.
https://510kreport.com/device/K080050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080050: Spirus Medical 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/K080050
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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