510(k) · Cleared
ClearedHowell Biliary Introducer 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 Jun 14, 2017 as substantially equivalent to K961897 (Wilson-Cook Medical, Inc., 1997) after a 440-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jun 14, 2017
- Review
- 440 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961897 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK961897 Wilson-Cook Biliary Introducer with Aspiration Biopsy NeedleWilson-Cook Medical, Inc. · 1997
- This deviceK160890 Howell Biliary Introducer NeedleWilson-Cook Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961897 | Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle | Wilson-Cook Medical, Inc. | 1997 | — |
| 0 (this device) | K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | 2017 | — |
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? (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 |
|---|---|---|---|
| * | K961897 | Wilson-Cook Biliary Introducer with Aspiration Biopsy NeedleSummary page 4…fication Name: Gastroenterology-Urology biopsy instrument 21 CFR 876.1075, FCG, Class II Predicate Device Wilson-Cook Aspiration Biopsy Needle (K961897) Intended Use The Howell Biliary Introducer Needle is used for aspiration biopsy in the biliary system. Device Description Th… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
The Howell Biliary Introducer Needle is used for aspiration biopsy in the biliary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160890: Howell Biliary Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160890
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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