# K170233: Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Zhanjiang Star Enterprise Co., Ltd.
- Decided: Oct 13, 2017 after 261 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: 4 generations back to K003784 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142575: Bard RiteCath Intermittent Urinary Catheter, C.R. Bard, Inc. (2014) Summary page 5.
- K130908: Disposable Silicone Foley Catheter, Guangdong Baihe Medical Technology Co., Ltd. (2013) Summary page 5.
- K071423: Medline Latex Foley Catheter, Medline Industries, Inc. (2007) Summary page 5.

## Indications for use
The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old. The Silicone Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old. The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean intermittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

Source page: https://510kreport.com/device/K170233
Methodology: https://510kreport.com/methodology