# K181690: Clear-Jet Injection Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Dec 21, 2018 after 178 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Clear-Jet Injection Catheter is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Source page: https://510kreport.com/device/K181690
Methodology: https://510kreport.com/methodology