510(k) · Cleared
ClearedShape-Lockable Endoscopic Overtube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usgi Medical, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Aug 20, 2003 as substantially equivalent to K903842 (Olympus Corp., 1991) and 2 other predicates after a 271-day review. Its family tree reaches back 2 generations to 1994. 17 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 271 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942044 (1994). 4 ancestors in all, the oldest K903842 (1991). 17 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- 1 generation backK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- This deviceK023902 Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003
- Descendant · cites it directly · 16 of its ownK033954 Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004
- Descendant · 2 generations on · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · 2 generations on · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- Descendant · 3 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 4 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K033954Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004 · cites it directly16descendants
- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · 2 generations on13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · 2 generations on12descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| −1 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| 0 (this device) | K023902 | Shape-Lockable Endoscopic Overtube | Usgi Medical, Inc. | 2003 | — |
| +1 | K033954 | Shape Locking Endoscopic Overtube | Usgi Medical, Inc. | 2004 | — |
| +2 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +2 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +3 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +4 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K903842 | ST-E1 OvertubeSummary page 4…e CLASSIFICATION NAME: Endoscope and accessories DEVICE Class 2 per 21 CFR §876.1500 CLASSIFICATION: ProbucTt CODE 78 (KOG) PREDICATE DEVICE: Olympus ST-C3 Overtube (K903842), the Bard Endoscopic Overtube (K973500), and the NDO Surgical, inc. Overtube (K002018) DESCRIPTION OF THE DEVICE SUBJECT TO PR… | 1991 |
| * | K973500 | Bard Endoscopic Overtube (#000307)Summary page 4…ccessories DEVICE Class 2 per 21 CFR §876.1500 CLASSIFICATION: ProbucTt CODE 78 (KOG) PREDICATE DEVICE: Olympus ST-C3 Overtube (K903842), the Bard Endoscopic Overtube (K973500), and the NDO Surgical, inc. Overtube (K002018) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The USGI Endoscop… | 1997 |
| * | K002018 | Ndo Surgical Surgical OvertubeSummary page 4…LASSIFICATION: ProbucTt CODE 78 (KOG) PREDICATE DEVICE: Olympus ST-C3 Overtube (K903842), the Bard Endoscopic Overtube (K973500), and the NDO Surgical, inc. Overtube (K002018) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The USGI Endoscopic Overtube is an endoscopic accessory designed… | 2000 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033954 | Shape Locking Endoscopic Overtube | 2004 | 16 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K033954 (Usgi Medical, Inc., 2004) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K903842.
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 USGI Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
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/K023902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023902: Shape-Lockable 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/K023902
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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