# K210917: Single Use Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Anrei Medical (Hangzhou) Co., Ltd.
- Decided: May 28, 2021 after 60 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 K955558 (1996). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150434: Injection Needle, Micro-Tech (Nanjing) Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K240675: Endoscopic Injection Needles (2024), 0 descendants of its own
- K230925: Disposable Injection Needle AF series (2023), 0 descendants of its own
- K213239: Endoscopic Injection Needle (2022), 0 descendants of its own

## 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/K210917
Methodology: https://510kreport.com/methodology