# K213239: Endoscopic Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Zksk Technology Co., Ltd.
- Decided: Jun 2, 2022 after 245 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 4.

## Indications for use
Single use injection needle is 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 GI tract.

Source page: https://510kreport.com/device/K213239
Methodology: https://510kreport.com/methodology