RENAX A.V. FISTULA NEEDLE SETS— 510(k) K003123

Substantially Equivalent

Sunder Biomedical Tech. Co., Ltd.

FDA 510(k) clearance K003123 for RENAX A.V. FISTULA NEEDLE SETS, Substantially Equivalent on 2001-05-04. Applicant: Sunder Biomedical Tech. Co., Ltd..

Clearance details

Applicant: Sunder Biomedical Tech. Co., Ltd.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2000-10-05
Decision date: 2001-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.