510(k) · Cleared
ClearedNeuroscout Steerable Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 16, 2010 as substantially equivalent to K991646 (Cordis Neurovascular, Inc., 1999) and 2 other predicates after a 32-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 32 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K991646 (1999). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991646 Agility Steerable GuidewireCordis Neurovascular, Inc. · 1999
- This deviceK100351 Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121776 Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK151825 Viradius NeurowireMivi Neuroscience, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK133625 Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard &…Codman & Shurtleff, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K121776Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012 · cites it directly1descendant
- K151825Viradius NeurowireMivi Neuroscience, Inc. · 2015 · cites it directly0descendants
- K133625Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM &…Codman & Shurtleff, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991646 | Agility Steerable Guidewire | Cordis Neurovascular, Inc. | 1999 | — |
| 0 (this device) | K100351 | Neuroscout Steerable Guidewire | Codman & Shurtleff, Inc. | 2010 | — |
| +1 | K121776 | Agility Steerable Guidewire Neuroscout Steerable Gudiewire | Codman & Shurtleff, Inc. | 2012 | — |
| +1 | K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | 2015 | — |
| +2 | K133625 | Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN… | Codman & Shurtleff, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K991646 | Agility Steerable GuidewireSummary page 1…Catheter Guidewire Classification Name: Wire, Guide, Catheter Regulation Number: 870.1330 C. Predicate Device: AGILITY® Steerable Guidewire (K991646) (.012) AGILITY® Steerable Guidewire (K001033) (.014) AGILITY® Steerabl… | 1999 |
| * | K001033 | Agility Steerable GuidewireSummary page 1…egulation Number: 870.1330 C. Predicate Device: AGILITY® Steerable Guidewire (K991646) (.012) AGILITY® Steerable Guidewire (K001033) (.014) AGILITY® Steerable Guidewire (KOlO0I11) (.016) D. Device Description: The hydrophilic… | 2000 |
| * | K010511 | Modification to: Agility Steerable Guidewires Our reading of the summary gave K010011, FDA’s number for TE-2000 Power Tilt/Power Elevating Seat Combination System (Accelerated Rehab Designs, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AGILITY® Steerable Guidewire”. | 2001 |
What descends from it? (3)
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 DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The NEUROSCOUT™ Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100351: Neuroscout Steerable Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100351
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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