# K132065: Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Jan 17, 2014 after 198 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: 2 generations back to K955558 (1996). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061222: Injectra Injection Needle, Medi-Globe Corp. (2006) Summary page 1.

## Most influential descendants
- K153625: Single Use Injector NM600/610 (2016), 4 descendants of its own
- K213914: Injection Needle (2022), 2 descendants of its own
- K252021: Disposable Endoscopic Injection Needles (2025), 0 descendants of its own
- K252247: Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) (2025), 0 descendants of its own
- K232200: Disposable Injection Needles (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K132065
Methodology: https://510kreport.com/methodology