510(k) · Cleared
ClearedRadius Next Generation Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radius Medical Technologies, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Aug 23, 2001 as substantially equivalent to K942677 (Boston Scientific Corp, 1994) after a 78-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Aug 23, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942677 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942677 Geenen/Zebra GuidelinesBoston Scientific Corp · 1994
- This deviceK011759 Radius Next Generation GuidewireRadius Medical Technologies, Inc. · 2001
- 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 ownK050304 FX Wire Advanced Measurement GuidewireConmedcorp · 2005
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
- K050304FX Wire Advanced Measurement GuidewireConmedcorp · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942677 | Geenen/Zebra Guidelines | Boston Scientific Corp | 1994 | — |
| 0 (this device) | K011759 | Radius Next Generation Guidewire | Radius Medical Technologies, Inc. | 2001 | — |
| +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 | K050304 | FX Wire Advanced Measurement Guidewire | Conmedcorp | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K942677 | Geenen/Zebra GuidelinesSummary page 4…sory 3. Identification of Predicate or Legally Marketed Device The Next Generation Guidewire is substantially equivalent to the Microvasive Geenen Endotorque Guidewire (K942677) Boston Scientific Microvasive Jagwire (510(k) number unknown) 4, Device Description Radius Medical Technologies, Inc. has devel… | 1994 |
| * | — | Boston Scientific Microvasive Jagwire Named without a submission number |
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 Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but-not limited to the common bile duct, 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/K011759 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011759: Radius Next Generation Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011759
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026