510(k) · Cleared
ClearedInterject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FCG Biopsy Needle
Cleared on Oct 24, 2001 as substantially equivalent to K961846 (Boston Scientific Corp, 1996) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Oct 24, 2001
- Review
- 58 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961846 (1996). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961846 Needle CatheterBoston Scientific Corp · 1996
- This deviceK012864 Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816…Boston Scientific Corp · 2001
- Descendant · cites it directly · 7 of its ownK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK190032 Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK220292 Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK212668 Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK241595 EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · cites it directly7descendants
- K190032Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020 · 2 generations on3descendants
- K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K212668Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961846 | Needle Catheter | Boston Scientific Corp | 1996 | — |
| 0 (this device) | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… | Boston Scientific Corp | 2001 | — |
| +1 | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | 2 |
| +2 | K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +2 | K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
| +3 | K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
| +3 | K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K961846 | Needle CatheterSummary page 2…itional indications is substantially equivalent to the currently marketed Boston Scientific Corporation’s Interject™ Injection Therapy Needle, Variject™ Needle Catheter (K961846) and US Endoscopy Goup, Coaxial Needle (K971842). The major components of the devices are the catheter, needle, and hub. A thorou… | 1996 |
| * | K971842 | Coaxial NeedleSummary page 2…to the currently marketed Boston Scientific Corporation’s Interject™ Injection Therapy Needle, Variject™ Needle Catheter (K961846) and US Endoscopy Goup, Coaxial Needle (K971842). The major components of the devices are the catheter, needle, and hub. A thorough comparison of the descriptive characteristics… | 1997 |
| * | — | Interject™ Injection Therapy Needle Named without a submission number |
What descends from it? (9)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K171454 (Boston Scientific Corporation, 2017) has gone furthest, with 7 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 Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a
sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding
lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal
Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.
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/K012864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012864: Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012864
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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