# K961846: Needle Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 15, 1996 after 63 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012864: Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 (2001), 9 descendants of its own
- K171454: Interject Injection Therapy Needle Catheter (2017), 7 descendants of its own
- K190032: Disposable Sclerotherapy Needle (2020), 3 descendants of its own
- K220292: Disposable Endoscope Injection Needle (2022), 1 descendant of its own
- K212668: Sclerotherapy Needle (2022), 1 descendant of its own

Source page: https://510kreport.com/device/K961846
Methodology: https://510kreport.com/methodology