# K172278: Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Nov 22, 2017 after 117 days
- Product code: GBM (Catheter, Urethral)
- 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)
- K820313: Vpi-Fair Urethral Stent, Vance Products, Inc. (1982) Summary page 7.
- K130908: Disposable Silicone Foley Catheter, Guangdong Baihe Medical Technology Co., Ltd. (2013) Summary page 7.

## Indications for use
This device is used for stenting the urethra during hypospadias or epispadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).

Source page: https://510kreport.com/device/K172278
Methodology: https://510kreport.com/methodology