510(k) · Cleared
ClearedColonic Splinting Overtube, Model 00711145
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 Oct 20, 2009 as substantially equivalent to K023259 (Helix Medical, Inc., 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1986. 5 later devices descend from it.
- Decided
- Oct 20, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K853585 (1986). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK023259 Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc. · 2002
- This deviceK092221 Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc. · 2009
- 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
- Descendant · cites it directly · 0 of its ownK123013 Endoscopic IntroducerNovadaq Technologies, Inc. · 2013
Most influential descendants
Showing 5 of 5 · 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
- K123013Endoscopic IntroducerNovadaq Technologies, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K023259 | Inhealth Soft Sleeve Colonoscope Splint, Model CS1200 | Helix Medical, Inc. | 2002 | — |
| 0 (this device) | K092221 | Colonic Splinting Overtube, Model 00711145 | United States Endoscopy Group, Inc. | 2009 | — |
| +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 | — |
| +1 | K123013 | Endoscopic Introducer | Novadaq Technologies, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K023259 | Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Summary page 1…d Accessories Device Classification: Class II, per 21 CFR 876.1500 Product Code: 78 (FDF) Predicate Devices: K023259 Soft Sleeve Colonoscope Splint (International Healthcare Technologies, a… | 2002 |
| * | K052084 | Endo-Ease Endoscopic OvertubeSummary page 1…(International Healthcare Technologies, a division of Helix Medical, Inc.) K052084 Endo-Ease Tm Advantage Endoscopic Overtube (Spirus Medical, Inc.)… | 2005 |
| * | K040836 | Disposable OvertubeSummary page 1…K052084 Endo-Ease Tm Advantage Endoscopic Overtube (Spirus Medical, Inc.) K040836 Guardus® Overtube (US Endoscopy) CONFIDENTIAL… | 2004 |
What descends from it? (5)
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 23 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 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. 2009, 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 Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092221: Colonic Splinting Overtube, Model 00711145.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092221
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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