510(k) · Cleared
ClearedBard Director Guidewire (000560)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Feb 26, 1997 as substantially equivalent to K942677 (Boston Scientific Corp, 1994) and 2 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Feb 26, 1997
- Review
- 91 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910497 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910497 Wilson Cook Wire Guide and Protective GuideWilson-Cook Medical, Inc. · 1991
- This deviceK964780 Bard Director Guidewire (000560)C.R. Bard, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910497 | Wilson Cook Wire Guide and Protective Guide | Wilson-Cook Medical, Inc. | 1991 | — |
| 0 (this device) | K964780 | Bard Director Guidewire (000560) | C.R. Bard, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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 OCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K942677 | Geenen/Zebra GuidelinesSummary page 2…é64740 fl_o" ~ g ¢ Similaritics and Diff The Bard ®Director™ Guidewire is substantially equivalent to the currently marketed Microvasive® Geenen Endotorque™ Guidewire (#K942677/A), the Wilson-Cook® Tracer™ Wire Guide (#K910497), and the Davol® Laparoscopic Suction Irrigation Probe (#K941334). The indicat… | 1994 |
| * | K910497 | Wilson Cook Wire Guide and Protective GuideSummary page 2…®Director™ Guidewire is substantially equivalent to the currently marketed Microvasive® Geenen Endotorque™ Guidewire (#K942677/A), the Wilson-Cook® Tracer™ Wire Guide (#K910497), and the Davol® Laparoscopic Suction Irrigation Probe (#K941334). The indication statements are different, however, the Directo… | 1991 |
| * | K941334 | Davol Laparoscopic Suction Irrigation ProbeSummary page 2…y marketed Microvasive® Geenen Endotorque™ Guidewire (#K942677/A), the Wilson-Cook® Tracer™ Wire Guide (#K910497), and the Davol® Laparoscopic Suction Irrigation Probe (#K941334). The indication statements are different, however, the Director guidewire has the same intended use as the Geenen Endotorque gu… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K942677.
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCY
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OCY
51in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCY
8in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCY
133in 2025
MAUDE reports naming product code OCY, 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 | — | 0 | 3 |
| 2008 | 3 | 55 | 0 | 7 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 60 | 0 | 32 |
| 2014 | 5 | 41 | 0 | 51 |
| 2015 | 3 | 51 | 0 | 283 |
| 2016 | 1 | — | 0 | 158 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 101 |
| 2019 | 0 | — | 8 | 103 |
| 2020 | 0 | — | 0 | 128 |
| 2021 | 0 | — | 0 | 94 |
| 2022 | 0 | — | 0 | 134 |
| 2023 | 0 | — | 0 | 115 |
| 2024 | 0 | — | 0 | 131 |
| 2025 | 0 | — | 0 | 133 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use with devices having a .035" guidewire compatible lumen. The Director guidewire is used to guide endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts.
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/K964780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964780: Bard Director Guidewire (000560).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964780
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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