Wellead® Latex Foley Catheter— 510(k) K233094

Substantially Equivalent

Well Lead Medical (Hainan) Co., Ltd.

FDA 510(k) clearance K233094 for Wellead® Latex Foley Catheter, Substantially Equivalent on 2024-06-06. Applicant: Well Lead Medical (Hainan) Co., Ltd..

Clearance details

Applicant: Well Lead Medical (Hainan) Co., Ltd.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-26
Decision date: 2024-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haikou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJC

product code MJC

Injury: 398
Malfunction: 12,582
Other: 2
Total: 12,982

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.