# K230925: Disposable Injection Needle AF series

- Pathway: 510(k) (Traditional)
- Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
- Decided: Sep 27, 2023 after 177 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 K955558 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210917: Single Use Injection Needle, Anrei Medical (Hangzhou) Co., Ltd. (2021) Summary page 5.

## Indications for use
The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the Gl tract.

Source page: https://510kreport.com/device/K230925
Methodology: https://510kreport.com/methodology