VARICES NEEDLE— 510(k) K031238

Name: FDA 510(k) clearance K031238
Creator: U.S. Food and Drug Administration
Published: 2004-10-04

Substantially Equivalent

Scandimed. A.S.

FDA 510(k) clearance K031238 for VARICES NEEDLE, Substantially Equivalent on 2004-10-04. Applicant: Scandimed. A.S.. Device class: 2.

Clearance details

Applicant: Scandimed. A.S.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-04-18
Decision date: 2004-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collegeville, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.