# K022484: Cook Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Oct 25, 2002 after 88 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: 4 generations back to K820973 (1982). 8 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 21 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.
- K960519: Martech Endoscopic Injection Needle, Martech Medical Products, Inc. (1996) Summary page 1.
- K990996: Genyx Medical Injection Needle, Genyx Medical, Inc. (1999) Summary page 1.
- K983765: Injection Needle Probe/Device-Tunis, Ximed/Prosure/Injectx (1998) Summary page 1.
- K812057: Vance Cystoscopic, Vance Products, Inc. (1981) Summary page 1.

## Most influential descendants
- 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
- K171602: Williams Cystoscopic Injection Needle (2017), 1 descendant of its own

## Indications for use
The Cook Injection Needles are used to deliver a variety of injectable materials into tissues during laparoscopic, hysteroscopic, cystoscopic, endoscopic transurethral procedures and open surgical procedures. The type of material to be injected will be dependent on the nature of the procedure. The needle is intended to be used with legally marketed drugs and devices.

Source page: https://510kreport.com/device/K022484
Methodology: https://510kreport.com/methodology