Ambu Duodeno System— 510(k) K201098

Substantially Equivalent

Ambu Innovation GmbH

FDA 510(k) clearance K201098 for Ambu Duodeno System, Substantially Equivalent on 2020-07-17. Applicant: Ambu Innovation GmbH.

Clearance details

Applicant: Ambu Innovation GmbH
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2020-04-24
Decision date: 2020-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kissing, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.