510(k) · Cleared
ClearedNdo Surgical Surgical Overtube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Aug 17, 2000 as substantially equivalent to K973500 (C.R. Bard, Inc., 1997) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1994. 20 later devices descend from it.
- Decided
- Aug 17, 2000
- Review
- 45 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942044 (1994). 2 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- This deviceK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- Descendant · cites it directly · 17 of its ownK023902 Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003
- Descendant · 2 generations on · 16 of its ownK033954 Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004
- Descendant · 3 generations on · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- Descendant · 4 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K023902Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003 · cites it directly17descendants
- K033954Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004 · 2 generations on16descendants
- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · 3 generations on13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · 3 generations on12descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| 0 (this device) | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| +1 | K023902 | Shape-Lockable Endoscopic Overtube | Usgi Medical, Inc. | 2003 | — |
| +2 | K033954 | Shape Locking Endoscopic Overtube | Usgi Medical, Inc. | 2004 | — |
| +3 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +3 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +4 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 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? (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 |
|---|---|---|---|
| * | K973500 | Bard Endoscopic Overtube (#000307)Summary page 4…887 Contact Individual: Jeff Cerier 2. Device Name NDO Surgical, Inc. Overtube 3. Identification of Predicate or Legally Marketed Device C. R. Bard Endoscopic Overtube K973500, K942044 4. Device Description The NDO Surgical, Inc. Overtube is an extruded, flexible, polyvinyl chloride tube, reinforced wit… | 1997 |
| * | K942044 | Bard Endoscopic OvertubeSummary page 4…ct Individual: Jeff Cerier 2. Device Name NDO Surgical, Inc. Overtube 3. Identification of Predicate or Legally Marketed Device C. R. Bard Endoscopic Overtube K973500, K942044 4. Device Description The NDO Surgical, Inc. Overtube is an extruded, flexible, polyvinyl chloride tube, reinforced with stainle… | 1994 |
What descends from it? (20)
See all 202 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?
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 NDO Surgical, Inc. Overtube is indicated for endoscopic use when repeated endoscopic intubation is anticipated.
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/K002018 · printed Nov 3, 2026
Cite this page
510(k) Report. “K002018: Ndo Surgical Surgical Overtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002018
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026