510(k) · Cleared
ClearedFlexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire (Regular Shaft/Stiff Shaft) NO Marking
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexmedics · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Feb 14, 1997 as substantially equivalent to K931650 (Boston Scientific Corp, 1993) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Feb 14, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931650 (1993). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931650 Microvasive Insurg Geenen CBD Guide WireBoston Scientific Corp · 1993
- This deviceK964955 Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…Flexmedics · 1997
- Descendant · cites it directly · 2 of its ownK023603 Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK051068 Zutron Colonoscope Stiffening DeviceZutron Medical · 2005
- Descendant · 3 generations on · 0 of its ownK251204 FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · cites it directly · 0 of its ownK012556 Reprocessed GuidewiresSterilmed, Inc. · 2002 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K023603Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003 · cites it directly2descendants
- K051068Zutron Colonoscope Stiffening DeviceZutron Medical · 2005 · 2 generations on1descendant
- K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025 · 3 generations on0descendants
- K012556Reprocessed GuidewiresSterilmed, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931650 | Microvasive Insurg Geenen CBD Guide Wire | Boston Scientific Corp | 1993 | — |
| 0 (this device) | K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands… | Flexmedics | 1997 | — |
| +1 | K023603 | Endo-Glide Guidewire | Endo-Therapeutics, Inc. | 2003 | — |
| +2 | K051068 | Zutron Colonoscope Stiffening Device | Zutron Medical | 2005 | — |
| +3 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +1 | K012556 | Reprocessed Guidewires | Sterilmed, Inc. | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2025 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K910597 | FDA’s K910597 is Sunglasses Model #SP Promo #1 and SP Promo #2 Our OCR of the scanned summary read K910597, FDA’s number for Sunglasses Model #SP Promo #1 and SP Promo #2 (Radix Group Intl.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Protector Plus Guidewire”. Kept off the family tree. Summary page 1…nd (Electrosurgical) 21 CFR Part 876.4300. Common or Usual Name: Guidewire Proprietary Name: FlexFinder® guidewire Wilson-Cook Medical, Inc. Protector Plus Guidewire K910597 Boston Scientific Corporation Zebra Guidewire K931650 FlexMedics Corporation, Inc. FlexFinder Guidewire K942074 The FlexFinder®… | 1991 |
| * | K931650 | Microvasive Insurg Geenen CBD Guide WireSummary page 1…Usual Name: Guidewire Proprietary Name: FlexFinder® guidewire Wilson-Cook Medical, Inc. Protector Plus Guidewire K910597 Boston Scientific Corporation Zebra Guidewire K931650 FlexMedics Corporation, Inc. FlexFinder Guidewire K942074 The FlexFinder® Guidewire is available in a nominal diameter of 0.035”… | 1993 |
| * | K942074 | Flexfinder GuidewireSummary page 1…ewire Wilson-Cook Medical, Inc. Protector Plus Guidewire K910597 Boston Scientific Corporation Zebra Guidewire K931650 FlexMedics Corporation, Inc. FlexFinder Guidewire K942074 The FlexFinder® Guidewire is available in a nominal diameter of 0.035” with marked and unmarked models encompassing lengths betw… | 1994 |
What descends from it? (4)
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?
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 FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
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/K964955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964955: Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire (Regular Shaft/Stiff Shaft) NO Marking.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964955
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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