# K220292: Disposable Endoscope Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Decided: Aug 19, 2022 after 199 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961846 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171454: Interject Injection Therapy Needle Catheter, Boston Scientific Corporation (2017) Summary page 4.

## Most influential descendants
- K241595: EzVu Visual Vasopressor injector (EV-19) (2025), 0 descendants of its own

## Indications for use
The Disposable Endoscope Injection Needle 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/K220292
Methodology: https://510kreport.com/methodology