# K990996: Genyx Medical Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Genyx Medical, Inc.
- Decided: Jun 18, 1999 after 85 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: 3 generations back to K820973 (1982). 5 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982890: Advanced Uroscience Injection Needle, Advanced Uroscience, Inc. (1998) Summary page 1.
- (no number) Aspiration/ Injection Needle: named in the summary without a submission number

## Most influential descendants
- K022484: Cook Injection Needle (2002), 12 descendants of its own
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 (2009), 2 descendants of its own
- K192498: Single Use Injector (2020), 1 descendant of its own
- K180214: Repris Bladder Injection System (2018), 1 descendant of its own

## Indications for use
The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

Source page: https://510kreport.com/device/K990996
Methodology: https://510kreport.com/methodology