# K173657: Radiance (TM) Clear Sharklet (R) Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 23, 2018 after 267 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K896053 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082815: Well Lead Silicone and Latex Foley Catheters, Well Lead Medical Instruments (2008) Summary page 4.

## Indications for use
This device is intended for providing drainage of urine from the urinary tract.

Source page: https://510kreport.com/device/K173657
Methodology: https://510kreport.com/methodology