A.V. FISTULA BLUNT NEEDLE SET— 510(k) K082882

Substantially Equivalent

Jms North America Corp.

FDA 510(k) clearance K082882 for A.V. FISTULA BLUNT NEEDLE SET, Substantially Equivalent on 2009-01-21. Applicant: Jms North America Corp..

Clearance details

Applicant: Jms North America Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2008-09-30
Decision date: 2009-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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.