510(k) · Cleared
Recalled · 2002Wilson-Cook Ultrasound Biopsy 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 Oct 19, 2001 as substantially equivalent to K926559 (Proact, Ltd., 1993) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 19, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926559 (1993). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926559 Proact Biopsy Needle EnchancementsProact, Ltd. · 1993
- This deviceK013356 Wilson-Cook Ultrasound Biopsy NeedleWilson-Cook Medical, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK083802 Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025…Medi-Globe Corporation · 2009
- Descendant · 2 generations on · 1 of its ownK172309 Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK212852 Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt…Micro-Tech (Nanjing) Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K083802Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025Medi-Globe Corporation · 2009 · cites it directly2descendants
- K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · 2 generations on1descendant
- K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926559 | Proact Biopsy Needle Enchancements | Proact, Ltd. | 1993 | — |
| 0 (this device) | K013356 | Wilson-Cook Ultrasound Biopsy Needle | Wilson-Cook Medical, Inc. | 2001 | — |
| +1 | K083802 | Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and… | Medi-Globe Corporation | 2009 | — |
| +2 | K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017 | 2 |
| +3 | K212852 | Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM)… | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 FCG? 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? (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 |
|---|---|---|---|
| * | K926559 | Proact Biopsy Needle EnchancementsSummary page 1…e do not exist. Intended Use: Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope. Predicate Device: ProAct Biopsy Needle ProAct Ltd. K926559/A Wilson-Cook Ultrasound Wilson-Cook Medical Inc. | K934356 Needle Substantial Equivalence: The Wilson-Cook Modified Ultrasound… | 1993 |
| * | K934356 | Wilson-Cook GI Aspiration NeedleSummary page 1…rough the accessory channel of an ultrasound endoscope. Predicate Device: ProAct Biopsy Needle ProAct Ltd. K926559/A Wilson-Cook Ultrasound Wilson-Cook Medical Inc. | K934356 Needle Substantial Equivalence: The Wilson-Cook Modified Ultrasound Biopsy Needle is substantially equivalent to the referenced… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083802 | Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025 | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2002 | Not classified | Z-0079-04 | Other | There is a possibility that the affected devices would not capture a biopsy during a procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K083802 (Medi-Globe Corporation, 2009) has gone furthest, with 2 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?
Used for soft tissue biopsy through the accessory channel of an uitrasound endoscope.
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/K013356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013356: Wilson-Cook Ultrasound Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013356
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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