Ambu® aScope Colon; Ambu® aBox 2— 510(k) K230332

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K230332 for Ambu® aScope Colon; Ambu® aBox 2, Substantially Equivalent on 2023-09-15. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2023-02-07
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.