# K082536: Cook Wire Guides

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Oct 27, 2008 after 55 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K132890: Suprapubic Catheter and Introducer Set (2014), 1 descendant of its own
- K182066: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (2018), 0 descendants of its own
- K113692: XENX (2012), 0 descendants of its own

## Recalls of this device
- Aug 16, 2022 · Class II · Z-1837-2022: 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: 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: 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: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K082536
Methodology: https://510kreport.com/methodology