510(k) · Cleared
ClearedBard Tiger Guidewire Model 000540
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 Oct 29, 1996 as substantially equivalent to K931650 (Boston Scientific Corp, 1993) and 1 other predicate after a 145-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 29, 1996
- Review
- 145 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931650 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK931650 Microvasive Insurg Geenen CBD Guide WireBoston Scientific Corp · 1993
- This deviceK962178 Bard Tiger Guidewire Model 000540C.R. Bard, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931650 | Microvasive Insurg Geenen CBD Guide Wire | Boston Scientific Corp | 1993 | — |
| 0 (this device) | K962178 | Bard Tiger Guidewire Model 000540 | C.R. Bard, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 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? (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 |
|---|---|---|---|
| * | K931650 | Microvasive Insurg Geenen CBD Guide WireSummary page 2…LNy L Summary of Similarities and Differences The Tiger™ guidewire is substantially equivalent to the currently marketed ‘Boston Scientifc Zebra™ exchange guidewire (K931650) and the Flexmedics Corporation FlexFinder guidewire (K923755). The tapered core material is the same as the Davol Laparoscopic… | 1993 |
| * | K923755 | Flex Finder GuidewireSummary page 2…dewire is substantially equivalent to the currently marketed ‘Boston Scientifc Zebra™ exchange guidewire (K931650) and the Flexmedics Corporation FlexFinder guidewire (K923755). The tapered core material is the same as the Davol Laparoscopic Suction Irrigation Probe (K941334), which received concurrence… | 1993 |
| † | K941334 | Davol Laparoscopic Suction Irrigation Probe | 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 2 ancestors has a recall.
- 1 other device also cites its predicate K931650.
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?
The Bard® Tiger™ guidewire is indicated for use with devices having a .035" guidewire compatible lumen. The Tiger guidewire is designed to guide and exchange endoscopic accessories into the G.l. Tract, including, but not limited to, the common bile, cystic, the right, and left hepatic and pancreatic ducts. It is not necessary to withdraw or remove the Tiger guidewire during sphincterotomy.
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/K962178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962178: Bard Tiger Guidewire Model 000540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962178
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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