# K151475: EndoChoice Select Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Feb 8, 2016 after 251 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)
- K132065: Injection Needle, Endochoice, Inc. (2014) Summary page 5.

## Indications for use
The EndoChoice Select injection needle is intended for endoscopic injection into the gastrointestinal mucosa.

Source page: https://510kreport.com/device/K151475
Methodology: https://510kreport.com/methodology