# K212668: Sclerotherapy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Feb 23, 2022 after 184 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: 4 generations back to K961846 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190032: Disposable Sclerotherapy Needle, Hangzhou AGS MedTech Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.

Source page: https://510kreport.com/device/K212668
Methodology: https://510kreport.com/methodology