510(k) · Cleared
ClearedWilson Cook Wire Guide and Protective Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Apr 2, 1991 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Apr 2, 1991
- Review
- 56 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK910497 Wilson Cook Wire Guide and Protective GuideWilson-Cook Medical, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK033754 Tracer Metro Smart Wire GuideWilson-Cook Medical, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK122816 Axcess Soft Tip Wire GuideWilson-Cook Medical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK133076 Novagold High Performance GuidewireNeometrics, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK150225 NovaGold High Performance GuidewireNeometrics, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK142950 Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K033754Tracer Metro Smart Wire GuideWilson-Cook Medical, Inc. · 2003 · cites it directly4descendants
- K122816Axcess Soft Tip Wire GuideWilson-Cook Medical, Inc. · 2012 · 2 generations on3descendants
- K133076Novagold High Performance GuidewireNeometrics, Inc. · 2014 · 3 generations on1descendant
- K150225NovaGold High Performance GuidewireNeometrics, Inc. · 2015 · 4 generations on0descendants
- K142950Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910497 | Wilson Cook Wire Guide and Protective Guide | Wilson-Cook Medical, Inc. | 1991 | — |
| +1 | K033754 | Tracer Metro Smart Wire Guide | Wilson-Cook Medical, Inc. | 2003 | — |
| +2 | K122816 | Axcess Soft Tip Wire Guide | Wilson-Cook Medical, Inc. | 2012 | — |
| +3 | K133076 | Novagold High Performance Guidewire | Neometrics, Inc. | 2014 | 1 |
| +4 | K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015 | — |
| +3 | K142950 | Acrobat Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 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, K033754 (Wilson-Cook Medical, Inc., 2003) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K910497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910497: Wilson Cook Wire Guide and Protective Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910497
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026