Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)— 510(k) K250269

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K250269 for Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection), Substantially Equivalent on 2025-06-11. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-30
Decision date: 2025-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.