# K202566: Wiygul Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Big Blue Biotech, Inc.
- Decided: Sep 30, 2020 after 26 days
- Product code: EZD (Catheter, Straight)
- 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: 2 generations back to K944782 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072997: Neomed Urinary Catheter, Neomed, Inc. (2007) Summary page 4.

## Indications for use
The Wiygul Catheter is intended for use in the neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter.

Source page: https://510kreport.com/device/K202566
Methodology: https://510kreport.com/methodology