# K171602: Williams Cystoscopic Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 28, 2017 after 57 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
Longest line of descent: 5 generations back to K820973 (1982). 9 ancestors in all.
1 later device descends from it; 1 cites 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)
- K022484: Cook Injection Needle, Cook Urological, Inc. (2002) Summary page 4.

## Most influential descendants
- K182876: Uro-N Cystoscope (2019), 0 descendants of its own

## Recalls of this device
- Sep 16, 2026 · Class II · Z-0163-2027: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur 

## Indications for use
The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.

Source page: https://510kreport.com/device/K171602
Methodology: https://510kreport.com/methodology