510(k) · Cleared
ClearedEndo-Glide Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endo-Therapeutics, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Feb 19, 2003 as substantially equivalent to K922302 (Boston Scientific Corp, 1992) and 2 other predicates after a 114-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 19, 2003
- Review
- 114 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931650 (1993). 6 ancestors in all, the oldest K922302 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931650 Microvasive Insurg Geenen CBD Guide WireBoston Scientific Corp · 1993
- 1 generation backK964955 Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…Flexmedics · 1997
- This deviceK023603 Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK051068 Zutron Colonoscope Stiffening DeviceZutron Medical · 2005
- Descendant · 2 generations on · 0 of its ownK251204 FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931650 | Microvasive Insurg Geenen CBD Guide Wire | Boston Scientific Corp | 1993 | — |
| −1 | K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands… | Flexmedics | 1997 | — |
| 0 (this device) | K023603 | Endo-Glide Guidewire | Endo-Therapeutics, Inc. | 2003 | — |
| +1 | K051068 | Zutron Colonoscope Stiffening Device | Zutron Medical | 2005 | — |
| +2 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922302 | Jagwire (TM) Recanalization GuidewireSummary page 4…Trade or Proprietary Name: Endo-Glide Guidewire Common Name: Guidewire Classified Name: Gastrointestinal Guidewire Equivalent Predicate Devices: Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759) Description of Device: The Endo-Glide Guidewire has a ra… | 1992 |
| * | K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire…Summary page 4…Glide Guidewire Common Name: Guidewire Classified Name: Gastrointestinal Guidewire Equivalent Predicate Devices: Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759) Description of Device: The Endo-Glide Guidewire has a range of diameters from 0.025” to 0.… | 1997 |
| * | K011759 | Radius Next Generation GuidewireSummary page 4…re Classified Name: Gastrointestinal Guidewire Equivalent Predicate Devices: Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759) Description of Device: The Endo-Glide Guidewire has a range of diameters from 0.025” to 0.035” and lengths from 250cm to 450cm.… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051068 | Zutron Colonoscope Stiffening Device | 2005 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K051068 (Zutron Medical, 2005) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K922302.
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?
Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
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/K023603 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023603: Endo-Glide Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023603
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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