510(k) · Cleared
ClearedEndoflip Ecd
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crospon, Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Oct 6, 2011 as substantially equivalent to K100081 (United States Endoscopy Group, Inc., 2010) and 1 other predicate after a 224-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Oct 6, 2011
- Review
- 224 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K993704 (2000). 15 ancestors in all, the oldest K853585 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 5 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 4 generations backK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
- 3 generations backK060235 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006
- 2 generations backK080050 Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008
- 1 generation backK100081 Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010
- This deviceK110531 Endoflip EcdCrospon, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK150083 Sidecar External Working ChannelC2 Therapeutics · 2015
Most influential descendants
Showing 1 of 1 · See all- K150083Sidecar External Working ChannelC2 Therapeutics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −5 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −4 | K052084 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2005 | — |
| −3 | K060235 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2006 | — |
| −2 | K080050 | Spirus Medical Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2008 | — |
| −1 | K100081 | Enteroscopy Overtube, Model 00712140 | United States Endoscopy Group, Inc. | 2010 | — |
| 0 (this device) | K110531 | Endoflip Ecd | Crospon, Ltd. | 2011 | — |
| +1 | 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 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K100081 | Enteroscopy Overtube, Model 00712140Summary page 1…sification!/ CFR: FED!/ CFR 876.1500 Device: EndoFLIP®D EGO EF-800 Predicate Devices: US Endoscopy Enteroscopy Overtube (K 100081) Smart Medical NaviAll) EGE (K060923) Device Description: The EndoFLIP® ECD EF-800 External Chann… | 2010 |
| * | K060923 | Naviaid Bge Device, Model 21-001Summary page 1…EndoFLIP®D EGO EF-800 Predicate Devices: US Endoscopy Enteroscopy Overtube (K 100081) Smart Medical NaviAll) EGE (K060923) Device Description: The EndoFLIP® ECD EF-800 External Channel Device (EGO) is an endoscopic accessory designed to provide an add… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150083 | Sidecar External Working Channel | 2015 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K150083 (C2 Therapeutics, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100081.
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. 2011, 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 EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures
The EndoFLIP® ECD is single patient use, disposable.
Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110531 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110531: Endoflip Ecd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110531
Report an extraction error
Are you the manufacturer?
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