Ambu® aScope Gastro Large; Ambu® aBox 2— 510(k) K232919

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K232919 for Ambu® aScope Gastro Large; Ambu® aBox 2, Substantially Equivalent on 2024-04-05. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-19
Decision date: 2024-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.