Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)— 510(k) K170233

Name: FDA 510(k) clearance K170233
Creator: U.S. Food and Drug Administration
Published: 2017-10-13

Substantially Equivalent

Zhanjiang Star Enterprise Co., Ltd.

FDA 510(k) clearance K170233 for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter), Substantially Equivalent on 2017-10-13. Applicant: Zhanjiang Star Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhanjiang Star Enterprise Co., Ltd.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2017-01-25
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhanjiang, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Zhanjiang Star Enterprise Co., Ltd.

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K170234 — Endotracheal tube; Reinforced Endotracheal tube2018-01-17

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.