510(k) · Cleared
ClearedGore Angioscopic Valvvlotome Kit (TBD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · LYK Angioscope
Cleared on Feb 20, 1997 as substantially equivalent to K930011 (Uresil Corp., 1993) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 20, 1997
- Review
- 133 days
- Class
- Class II
- Product code
- LYK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923996 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923996 Disposable Vascular AngioscopeEndovascular, Inc. · 1993
- This deviceK964061 Gore Angioscopic Valvvlotome Kit (TBD)W. L. Gore & Associates, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923996 | Disposable Vascular Angioscope | Endovascular, Inc. | 1993 | — |
| 0 (this device) | K964061 | Gore Angioscopic Valvvlotome Kit (TBD) | W. L. Gore & Associates, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 LYK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYK device
- #1 K253842 Vena MicroAngioscope™ Systemscore 10.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K930011 | Uresil Valve Cutter with Interchangeable HeadsSummary page 1…of determining substantial equivalence, GORE cites the following as predicate devices : URESIL Valvulotome (marketed under contract as the “GORE EZE-Sit Valvulotome”) - K 930011 CLARUS Angioscope - K 900894 NEURONAVIGATIONAL Angioscope - K 923996 NOTE: One of these two, or any other FDA-cleared, commercial… | 1993 |
| Kept off the family tree | K900894 | FDA’s K900894 is Medilase Series 2100 Endoscope Our OCR of the scanned summary read K900894, FDA’s number for Medilase Series 2100 Endoscope (Medical Laser, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CLARUS Angioscope”. Kept off the family tree. Summary page 1…uivalence, GORE cites the following as predicate devices : URESIL Valvulotome (marketed under contract as the “GORE EZE-Sit Valvulotome”) - K 930011 CLARUS Angioscope - K 900894 NEURONAVIGATIONAL Angioscope - K 923996 NOTE: One of these two, or any other FDA-cleared, commercially marketed, angioscopes wil… | 1990 |
| * | K923996 | Disposable Vascular AngioscopeSummary page 1…redicate devices : URESIL Valvulotome (marketed under contract as the “GORE EZE-Sit Valvulotome”) - K 930011 CLARUS Angioscope - K 900894 NEURONAVIGATIONAL Angioscope - K 923996 NOTE: One of these two, or any other FDA-cleared, commercially marketed, angioscopes will be used in the angioscopic valvulotome… | 1993 |
| * | — | GORE Irrigation System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K930011.
How does its category compare?
All LYK devicesLYK Angioscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYK
Too few LYK 510(k)s in any year since 2007 to give a median.
Recalls per year · LYK
No recall names LYK since 2007.
Adverse event reports per year · LYK
1in 2024
MAUDE reports naming product code LYK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.
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/K964061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964061: Gore Angioscopic Valvvlotome Kit (TBD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964061
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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