510(k) · Cleared
ClearedMicrovasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Aug 17, 1994 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Aug 17, 1994
- Review
- 15 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK943737 Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder GuidewireBoston Scientific Corp · 1994
- Descendant · cites it directly · 5 of its ownK053251 Techdevice GuidewireTechdevice Corporation · 2006
- Descendant · 2 generations on · 2 of its ownK110241 Endologix GuidewireTechdevice Corporation · 2011
- Descendant · 3 generations on · 1 of its ownK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- Descendant · 4 generations on · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK141218 Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire…Vadiswire Corporation · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K053251Techdevice GuidewireTechdevice Corporation · 2006 · cites it directly5descendants
- K110241Endologix GuidewireTechdevice Corporation · 2011 · 2 generations on2descendants
- K152177SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015 · 3 generations on1descendant
- K243061SonoStik Guide Wire IntroducerSonostik, LLC · 2024 · 4 generations on0descendants
- K141218Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire SystemVadiswire Corporation · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943737 | Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire | Boston Scientific Corp | 1994 | — |
| +1 | K053251 | Techdevice Guidewire | Techdevice Corporation | 2006 | — |
| +2 | K110241 | Endologix Guidewire | Techdevice Corporation | 2011 | — |
| +3 | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| +4 | K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024 | — |
| +2 | K141218 | Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System | Vadiswire Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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? (7)
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, K053251 (Techdevice Corporation, 2006) has gone furthest, with 5 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/K943737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943737: Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943737
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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