# K042882: Enteryx Injection Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 9, 2004 after 21 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Boston Scientific Enteryx® Injection Catheter: named in the summary without a submission number

## Recalls of this device
- Sep 23, 2005 · Not classified · Z-0040-06: Incorrect implantation may cause serious health complications

## Indications for use
Indicated for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varicies and for submucosal dye marking in the upper GI tract. The Enteryx® Injection Catheter is also a component of the Enteryx® Procedure Kit.

Source page: https://510kreport.com/device/K042882
Methodology: https://510kreport.com/methodology