Well Lead All Silicone Foley Catheter with Temperature Sensor— 510(k) K202134

Name: FDA 510(k) clearance K202134
Creator: U.S. Food and Drug Administration
Published: 2021-04-08

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K202134 for Well Lead All Silicone Foley Catheter with Temperature Sensor, Substantially Equivalent on 2021-04-08. Applicant: Well Lead Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-31
Decision date: 2021-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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K241424 — InnoCare Specialty Foley Catheter2024-09-18

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K220036 — Wellead Ureteral Catheter2022-12-16
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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.