Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact— 510(k) K241734

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K241734 for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact, Substantially Equivalent on 2025-03-05. Applicant: Well Lead Medical Co., Ltd..

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2024-06-17
Decision date: 2025-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.