510(k) · Cleared
ClearedWilson-Cook Usw Cap and Wire Lock
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 Feb 20, 2004 as substantially equivalent to K010610 (Boston Scientific Corp, 2001) after a 29-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970054 (1997). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970054 TandemrxBoston Scientific Corp · 1997
- 1 generation backK010610 Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001
- This deviceK040137 Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK213483 SnapLoc Wire LockWilson Cook Medical · 2022
- Descendant · cites it directly · 0 of its ownK220247 Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK202237 Locking deviceHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK190164 CleverLock Guidewire Locking Device and Biopsy CapOlympus Surgical Technologies America · 2019
Most influential descendants
Showing 4 of 4 · See all- K213483SnapLoc Wire LockWilson Cook Medical · 2022 · cites it directly0descendants
- K220247Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022 · cites it directly0descendants
- K202237Locking deviceHangzhou AGS MedTech Co., Ltd. · 2020 · cites it directly0descendants
- K190164CleverLock Guidewire Locking Device and Biopsy CapOlympus Surgical Technologies America · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970054 | Tandemrx | Boston Scientific Corp | 1997 | — |
| −1 | K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 | Boston Scientific Corp | 2001 | — |
| 0 (this device) | K040137 | Wilson-Cook Usw Cap and Wire Lock | Wilson-Cook Medical, Inc. | 2004 | — |
| +1 | K213483 | SnapLoc Wire Lock | Wilson Cook Medical | 2022 | — |
| +1 | K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +1 | K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +1 | K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Summary page 4…ire Lock USW Cap and Wire Lock Endascope Cap and Wire Lock Endoscope and/or Accessorsies 21 CFR § 876.1500. 78 KOG Microvasive RX Locking Device and Biopsy Cap System (k010610) . This device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedu… | 2001 |
What descends from it? (4)
4 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K213483 (Wilson Cook Medical, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K010610.
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 Wilson-Cook USW Cap and Wire Lock Device device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place dusing ERCP procedures.
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/K040137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040137: Wilson-Cook Usw Cap and Wire Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040137
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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