# K213914: Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
- Decided: Jul 29, 2022 after 226 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). 6 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K153625: Single Use Injector NM600/610, Olympus Medical Systems Corp. (2016) Summary page 5.

## Most influential descendants
- K252021: Disposable Endoscopic Injection Needles (2025), 0 descendants of its own
- K232200: Disposable Injection Needles (2024), 0 descendants of its own

## 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/K213914
Methodology: https://510kreport.com/methodology