# K082319: Injekt Filiform Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Sep 25, 2008 after 43 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: 5 generations back to K820973 (1982). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022484: Cook Injection Needle, Cook Urological, Inc. (2002) Summary page 1.
- K051905: Uroplasty Rigid Endoscopic Needle, Uroplasty, Inc. (2005)
- K982890: Advanced Uroscience Injection Needle, Advanced Uroscience, Inc. (1998) Summary page 1.
- K812057: Vance Cystoscopic, Vance Products, Inc. (1981) Summary page 1.

## Indications for use
Used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole.

Source page: https://510kreport.com/device/K082319
Methodology: https://510kreport.com/methodology