# K221054: Core-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Incore Co., Ltd.
- Decided: Dec 21, 2022 after 254 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 5.

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

Source page: https://510kreport.com/device/K221054
Methodology: https://510kreport.com/methodology