# K013712: Enteryx Injector

- Pathway: 510(k) (Traditional)
- Applicant: Enteric Medical Technologies
- Decided: May 31, 2002 after 204 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Enteric Medical Technologies Enteryx™ Injector Disposable Endoscopic Injection Catheter is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the upper GI tract.

Source page: https://510kreport.com/device/K013712
Methodology: https://510kreport.com/methodology