510(k) · Cleared
ClearedWilson-Cook GI Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FCG Biopsy Needle
Cleared on Jan 7, 1994 after a 122-day review. The FDA summary names its predicate without a number. 1 of the 70 devices in its family, counting itself, has a Class I recall. 69 later devices descend from it.
- Decided
- Jan 7, 1994
- Review
- 122 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 6 citing it directly. 1 of the 70 devices in this family, counting this one, has a Class I recall.
- This deviceK934356 Wilson-Cook GI Aspiration NeedleWilson-Cook Medical, Inc. · 1994
- Descendant · cites it directly · 49 of its ownK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- Descendant · cites it directly · 27 of its ownK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- Descendant · 2 generations on · 26 of its ownK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- Descendant · 2 generations on · 16 of its ownK112198 Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011
- Descendant · 2 generations on · 16 of its ownK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX4 generations on · 2020
Most influential descendants
Showing 5 of 69 · See all- K083330Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009 · cites it directly49descendants
- K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · cites it directly27descendants
- K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · 2 generations on26descendants
- K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011 · 2 generations on16descendants
- K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd. · 2009 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934356 | Wilson-Cook GI Aspiration Needle | Wilson-Cook Medical, Inc. | 1994 | — |
| +1 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| +1 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| +2 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| +2 | K112198 | Expect Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2011 | — |
| +2 | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A | Cook Ireland, Ltd. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 1 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Wilson-Cook Medical biopsy aspiration needles Named without a submission number |
What descends from it? (69)
See all 696 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083330 | Echotip Ultra Ultrasound Needle | 2009 | 49 |
| K100712 | Resound Endoscopic Ultrasound Aspiration Needle | 2010 | 27 |
| K013356 | Wilson-Cook Ultrasound Biopsy Needle | 2001 | 3 |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | 2017 | 0 |
| K052279 | Cook Ireland Echobrush | 2005 | 0 |
| K030618 | Wilson-Cook Celiac Plexus Neurolysis Needle | 2003 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K083330 (Cook Endoscopy, 2009) has gone furthest, with 49 descendants of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K934356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934356: Wilson-Cook GI Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934356
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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