APLAN A.V. FISTULA NEEDLE SET— 510(k) K112734

Substantially Equivalent

Aplan Well Enterprise Co., Ltd.

FDA 510(k) clearance K112734 for APLAN A.V. FISTULA NEEDLE SET, Substantially Equivalent on 2012-04-24. Applicant: Aplan Well Enterprise Co., Ltd..

Clearance details

Applicant: Aplan Well Enterprise Co., Ltd.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2011-09-20
Decision date: 2012-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu 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.