510(k) · Cleared
Recalled · Class II · 2016Coaxial Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Gynecology and Radiology · FCG Biopsy Needle
Cleared on Mar 22, 1994 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 22, 1994
- Review
- 83 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 3
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK936194 Coaxial Biopsy NeedleBard Gynecology and Radiology · 1994
- Descendant · cites it directly · 2 of its ownK160423 Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK181756 Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial NeedleApriomed AB · 2018
- Descendant · cites it directly · 0 of its ownK151373 Corvocet Coaxial IntroducerMerit Medical Systems, Inc. · 2015 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160423Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016 · cites it directly2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on1descendant
- K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 3 generations on0descendants
- K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial NeedleApriomed AB · 2018 · cites it directly0descendants
- K151373Corvocet Coaxial IntroducerMerit Medical Systems, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936194 | Coaxial Biopsy Needle | Bard Gynecology and Radiology | 1994 | — |
| +1 | K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016 | — |
| +2 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +3 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
| +1 | K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | 2018 | — |
| +1 | K151373 | Corvocet Coaxial Introducer | Merit Medical Systems, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2016 | Class II | Z-2547-2016 | Packaging | May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. |
| Feb 4, 2016 | Class II | Z-1396-2016 | Unknown/Undetermined by firm | Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial. |
| May 1, 2006 | Not classified | Z-0913-06 | Other | Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160423 (Corbin Clinical Resources, LLC, 2016) 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 | — |
https://510kreport.com/device/K936194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936194: Coaxial Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936194
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026