510(k) · Cleared
Recalled · Class II · 2022Cook Wire Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Oct 27, 2008 after a 55-day review. The FDA summary names no predicate by number. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 27, 2008
- Review
- 55 days
- Class
- Class II
- Product code
- OCY
- Recalls
- 7
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK082536 Cook Wire GuidesCook Urological, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK132890 Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK182066 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK113692 XENXXenolith Medical · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082536 | Cook Wire Guides | Cook Urological, Inc. | 2008 | — |
| +1 | K132890 | Suprapubic Catheter and Introducer Set | Mediplus, Ltd. | 2014 | — |
| +2 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018 | — |
| +1 | K113692 | XENX | Xenolith Medical | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2022 | Class II | Z-1837-2022 | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. |
| Jan 4, 2019 | Class II | Z-0961-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Jan 4, 2019 | Class II | Z-0962-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Jan 4, 2019 | Class II | Z-0963-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Jan 4, 2019 | Class II | Z-0964-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Jan 4, 2019 | Class II | Z-0959-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Jan 4, 2019 | Class II | Z-0960-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132890 (Mediplus, Ltd., 2014) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.
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?
Cook Urological Wire Guides are used for ureteral access, to establish a tract, and assist in the placement, replacement, and exchange of devices during urological procedures. For the Roadrunner Wire Guides the intended use also includes use in a torturous or kinked ureter, traversing a large stone enroute to the kidney, or in cases demanding enhanced control and high radiopacity. These wire guides are not intended for PTCA use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082536: Cook Wire Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082536
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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