# K142144: Disposable Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Instruments (Shanghai) Company Limited
- Decided: Jan 15, 2015 after 163 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: 1 generation back to K011484 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011484: Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1, Olympus Optical Co., Ltd. (2001) Summary page 6.

## Indications for use
Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy: 1. Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine. 2. Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine. 3. Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.

Source page: https://510kreport.com/device/K142144
Methodology: https://510kreport.com/methodology