510(k) · Cleared
ClearedWilson-Cook Celiac Plexus Neurolysis Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on May 27, 2003 as substantially equivalent to K941305 (Wilson-Cook Medical, Inc., 1994) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 27, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K934356 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK934356 Wilson-Cook GI Aspiration NeedleWilson-Cook Medical, Inc. · 1994
- This deviceK030618 Wilson-Cook Celiac Plexus Neurolysis NeedleWilson-Cook Medical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934356 | Wilson-Cook GI Aspiration Needle | Wilson-Cook Medical, Inc. | 1994 | — |
| 0 (this device) | K030618 | Wilson-Cook Celiac Plexus Neurolysis Needle | Wilson-Cook Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 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 BSP? 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 BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · 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 |
|---|---|---|---|
| * | K941305 | Wilson-Cook Variable Length GI Injection NeedleSummary page 4…II Predicate Devices: The Wilson-Cook Celiac Plexus Neurolysis Needle is comparable to predicate devices including the Wilson-Cook Variable Length GI Injection Needle (K941305), the Wilson-Cook Endoscopic Ultrasound Needle (K934356), and the InjecTx PercuTx- Injection/ Aspiration Needle Probe/Device (K99… | 1994 |
| * | K934356 | Wilson-Cook GI Aspiration NeedleSummary page 4…urolysis Needle is comparable to predicate devices including the Wilson-Cook Variable Length GI Injection Needle (K941305), the Wilson-Cook Endoscopic Ultrasound Needle (K934356), and the InjecTx PercuTx- Injection/ Aspiration Needle Probe/Device (K994151). Device Description: The Wilson-Cook Celiac Plex… | 1994 |
| * | K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesSummary page 4…ariable Length GI Injection Needle (K941305), the Wilson-Cook Endoscopic Ultrasound Needle (K934356), and the InjecTx PercuTx- Injection/ Aspiration Needle Probe/Device (K994151). Device Description: The Wilson-Cook Celiac Plexus Neurolysis Needle is comprised of a stainless steel echogenic pencil point… | 2000 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K941305.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Wilson-Cook Celiac Plexus Neurolysis Needle is used to deliver neurolysing agents to the celiac plexus under guidance by endoscopic ultrasound. It is supplied sterile and is intended for single use only.
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/K030618 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030618: Wilson-Cook Celiac Plexus Neurolysis Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030618
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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