# K232200: Disposable Injection Needles

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Xinwell Medical Technology Co., Ltd.
- Decided: Apr 12, 2024 after 262 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: 5 generations back to K955558 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213914: Injection Needle, Jiangsu Vedkang Medical Science and Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

Source page: https://510kreport.com/device/K232200
Methodology: https://510kreport.com/methodology