510(k) · Cleared
ClearedBard Endoscopic Overtube (#000307)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Oct 16, 1997 after a 30-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Oct 16, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 5 citing it directly.
- This deviceK973500 Bard Endoscopic Overtube (#000307)C.R. Bard, Inc. · 1997
- Descendant · cites it directly · 20 of its ownK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- Descendant · cites it directly · 18 of its ownK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
- 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
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K002018Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000 · cites it directly20descendants
- K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005 · cites it directly18descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973500 | Bard Endoscopic Overtube (#000307) | C.R. Bard, Inc. | 1997 | — |
| +1 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| +1 | K052084 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2005 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | — | Bard Endoscopic Overtube Named without a submission number | |
| * | — | Olympus Splinting Tube ST-C3 Named without a submission number |
What descends from it? (32)
See all 325 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?
- Of its descendants, K002018 (Surgical, Inc., 2000) has gone furthest, with 20 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?
To be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, 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/K973500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973500: Bard Endoscopic Overtube (#000307).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973500
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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