# K012977: Varices Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Endo-Therapeutics, Inc.
- Decided: Nov 2, 2001 after 58 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
Varices Injection Needles are used for endoscopic injection of legally marked sclerotherapy agent and dyes into esophageal or colonic varices

Source page: https://510kreport.com/device/K012977
Methodology: https://510kreport.com/methodology