PVC Hydrophilic Urethral Catheter— 510(k) K220722

Name: FDA 510(k) clearance K220722
Creator: U.S. Food and Drug Administration
Published: 2023-05-22

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K220722 for PVC Hydrophilic Urethral Catheter, Substantially Equivalent on 2023-05-22. Applicant: Well Lead Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2022-03-14
Decision date: 2023-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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K253295 — Coude Sleeved IC; Coude Plus Sleeved IC2026-05-18

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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.