# K232826: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)

- Pathway: 510(k) (Traditional)
- Applicant: Steris
- Decided: Mar 8, 2024 after 177 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: 5 generations back to K961846 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212668: Sclerotherapy Needle, Zhejiang Chuangxiang Medical Technology Co., Ltd. (2022) Summary page 6.

## Indications for use
These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

Source page: https://510kreport.com/device/K232826
Methodology: https://510kreport.com/methodology