510(k) · Cleared
ClearedMicrovasive Insurg Geenen CBD Guide Wire
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 Jun 25, 1993 after an 81-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
- Jun 25, 1993
- Review
- 81 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK931650 Microvasive Insurg Geenen CBD Guide WireBoston Scientific Corp · 1993
- Descendant · cites it directly · 4 of its ownK964955 Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…Flexmedics · 1997
- Descendant · 2 generations on · 2 of its ownK023603 Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK051068 Zutron Colonoscope Stiffening DeviceZutron Medical · 2005
- Descendant · 4 generations on · 0 of its ownK251204 FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK012556 Reprocessed GuidewiresSterilmed, Inc. · 2002 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K964955Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire…Flexmedics · 1997 · cites it directly4descendants
- K023603Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003 · 2 generations on2descendants
- K051068Zutron Colonoscope Stiffening DeviceZutron Medical · 2005 · 3 generations on1descendant
- K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025 · 4 generations on0descendants
- K012556Reprocessed GuidewiresSterilmed, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931650 | Microvasive Insurg Geenen CBD Guide Wire | Boston Scientific Corp | 1993 | — |
| +1 | K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands… | Flexmedics | 1997 | — |
| +2 | K023603 | Endo-Glide Guidewire | Endo-Therapeutics, Inc. | 2003 | — |
| +3 | K051068 | Zutron Colonoscope Stiffening Device | Zutron Medical | 2005 | — |
| +4 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +2 | K012556 | Reprocessed Guidewires | Sterilmed, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2025 | 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, K964955 (Flexmedics, 1997) 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/K931650 · printed Nov 5, 2026
Cite this page
510(k) Report. “K931650: Microvasive Insurg Geenen CBD Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931650
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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