# K171454: Interject Injection Therapy Needle Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 7, 2017 after 51 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961846 (1996). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012864: Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836, Boston Scientific Corp (2001) Summary page 4.
- K902736: NM Injection Needles, Olympus Corp. (1990) Summary page 4.
- K941305: Wilson-Cook Variable Length GI Injection Needle, Wilson-Cook Medical, Inc. (1994) Summary page 5.

## Most influential descendants
- K190032: Disposable Sclerotherapy Needle (2020), 3 descendants of its own
- K220292: Disposable Endoscope Injection Needle (2022), 1 descendant of its own
- K212668: Sclerotherapy Needle (2022), 1 descendant of its own
- K241595: EzVu Visual Vasopressor injector (EV-19) (2025), 0 descendants of its own
- K232826: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) (2024), 0 descendants of its own

## Recalls of this device
- Oct 10, 2022 · Class II · Z-0226-2023: ***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
- Oct 10, 2022 · Class II · Z-0225-2023: ***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

## Indications for use
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

Source page: https://510kreport.com/device/K171454
Methodology: https://510kreport.com/methodology