Ambu® aScope Duodeno 2, Ambu® aBox 2— 510(k) K233886

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K233886 for Ambu® aScope Duodeno 2, Ambu® aBox 2, Substantially Equivalent on 2024-04-16. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2023-12-08
Decision date: 2024-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

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.