510(k) · Cleared
Recalled · Class II · 2022Interject Injection Therapy Needle Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jul 7, 2017 as substantially equivalent to K012864 (Boston Scientific Corp, 2001) and 2 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 7, 2017
- Review
- 51 days
- Class
- Class II
- Product code
- FBK
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961846 (1996). 5 ancestors in all, the oldest K902736 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK961846 Needle CatheterBoston Scientific Corp · 1996
- 1 generation backK012864 Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816…Boston Scientific Corp · 2001
- This deviceK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017
- Descendant · cites it directly · 3 of its ownK190032 Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK220292 Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK212668 Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK241595 EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK232826 Articulator Injection Needle (00711807), Articulator Injection…Steris · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190032Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020 · cites it directly3descendants
- K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · cites it directly1descendant
- K212668Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd. · 2025 · 2 generations on0descendants
- K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…Steris · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961846 | Needle Catheter | Boston Scientific Corp | 1996 | — |
| −1 | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… | Boston Scientific Corp | 2001 | — |
| 0 (this device) | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | — |
| +1 | K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +1 | K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
| +2 | K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
| +2 | K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt, Ltd. | 2025 | — |
| +3 | K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle… | Steris | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FBK? 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 FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 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 |
|---|---|---|---|
| * | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825…Summary page 4…ce: InterjectTM Injection Therapy Needle Catheter Manufacturer: Boston Scientific Common Name: Injection Therapy Needle Catheter 510(k) Number: K012864 Classification Name: Biopsy Needle Regulation Number: 876.1075 Product Code: FCG Classification: Class II Name of De… | 2001 |
| * | K902736 | NM Injection NeedlesSummary page 4…Classification: Class II Name of Device: InjectorForce Max Single-Use Injection Needle Manufacturer: Olympus Medical Systems Corp. 510(k) Number: K902736 Classification Name: Endoscopic Injection Needle, Gastroenterology- Urology Regulation Number: 876.1500 Product Code: FBK… | 1990 |
| * | K941305 | Wilson-Cook Variable Length GI Injection NeedleSummary page 5…Page 2 of 3 Name of Device: Wilson-Cook Variable Length GI Injection Needle Manufacturer: Wilson-Cook Medical, Inc. 510(k) Number: K941305 Classification Name: Endoscopic Injection Needle, Gastroenterology- Urology Regulation Number: 876.1500 Product Code: FBK… | 1994 |
What descends from it? (7)
3 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 |
|---|---|---|---|---|
| Oct 10, 2022 | Class II | Z-0226-2023 | Under Investigation by firm | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which… |
| Oct 10, 2022 | Class II | Z-0225-2023 | Under Investigation by firm | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K190032 (Hangzhou AGS MedTech Co., Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K012864.
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Interject Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system
aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures
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/K171454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171454: Interject Injection Therapy Needle Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171454
Report an extraction error
Are you the manufacturer?
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