510(k) · Cleared
ClearedShape Locking 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 Mar 19, 2004 as substantially equivalent to K023902 (Usgi Medical, Inc., 2003) after an 88-day review. Its family tree reaches back 3 generations to 1994. 16 later devices descend from it.
- Decided
- Mar 19, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942044 (1994). 5 ancestors in all, the oldest K903842 (1991). 16 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- 2 generations backK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- 1 generation backK023902 Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003
- This deviceK033954 Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- 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 · 3 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · cites it directly13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · cites it directly12descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on5descendants
- K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| −2 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| −1 | K023902 | Shape-Lockable Endoscopic Overtube | Usgi Medical, Inc. | 2003 | — |
| 0 (this device) | K033954 | Shape Locking Endoscopic Overtube | Usgi Medical, Inc. | 2004 | — |
| +1 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +1 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +2 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +3 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +3 | K141286 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2014 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K023902 | Shape-Lockable Endoscopic OvertubeSummary page 4…ON NAME: Endoscope and accessories DEVICE Class 2 per 21 CFR §876.1500 CLASSIFICATION: PRODUCT CODE 78 (KOG) PREDICATE DEVICE: USGI Shape Locking Endoscopic Overtube (K023902) SUBSTANTIALLY EQUIVALENT TO: USGI Shape Locking Endoscopic Overtube (cleared for market under K023902) DESCRIPTION OF THE DEVI… | 2003 |
What descends from it? (16)
See all 164 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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K052930 (Neoguide Systems, Inc., 2006) has gone furthest, with 13 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.
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 Shape Locking 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/K033954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033954: Shape Locking 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/K033954
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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