# K190829: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
- Decided: Dec 19, 2019 after 262 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: 1 generation back to K941305 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941305: Wilson-Cook Variable Length GI Injection Needle, Wilson-Cook Medical, Inc. (1994) Summary page 4.

## Indications for use
This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.

Source page: https://510kreport.com/device/K190829
Methodology: https://510kreport.com/methodology