# K031238: Varices Needle

- Pathway: 510(k) (Traditional)
- Applicant: Scandimed. A.S.
- Decided: Oct 4, 2004 after 535 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 Varices Needle is used to inject sclerotherapy agent into varices in the esophagus and colon, via an endoscope using direct visualization. The Varices Needle is intended for single use only.

Source page: https://510kreport.com/device/K031238
Methodology: https://510kreport.com/methodology