# K941305: Wilson-Cook Variable Length GI Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 2, 1994 after 77 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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; 3 cite 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
- 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
- K241595: EzVu Visual Vasopressor injector (EV-19) (2025), 0 descendants of its own

## Recalls of this device
- Jun 14, 2019 · Class II · Z-2089-2019: Potential for occluded injection needles.

Source page: https://510kreport.com/device/K941305
Methodology: https://510kreport.com/methodology