510(k) · Cleared
Recalled · Class II · 2016Coaxial Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FCG Biopsy Needle
Cleared on Jun 20, 1997 after a 32-day review. The FDA summary names no predicate by number. 10 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 1997
- Review
- 32 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK971842 Coaxial NeedleUnited States Endoscopy Group, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK012864 Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816…Boston Scientific Corp · 2001
- Descendant · 2 generations on · 7 of its ownK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK190032 Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220292 Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK212668 Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012864Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825…Boston Scientific Corp · 2001 · cites it directly9descendants
- K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · 2 generations on7descendants
- K190032Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020 · 3 generations on3descendants
- K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K212668Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971842 | Coaxial Needle | United States Endoscopy Group, Inc. | 1997 | — |
| +1 | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… | Boston Scientific Corp | 2001 | — |
| +2 | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | 2 |
| +3 | K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +3 | K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
| +4 | K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by number.
What descends from it? (10)
2 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 |
|---|---|---|---|---|
| May 18, 2016 | Class II | Z-0289-2017 | Other | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012864 (Boston Scientific Corp, 2001) has gone furthest, with 9 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?
The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the needle in order to flush the injection site for better visualization.
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/K971842 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971842: Coaxial Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971842
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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