Ambu aScope 4 Cysto— 510(k) K193095

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K193095 for Ambu aScope 4 Cysto, Substantially Equivalent on 2020-04-02. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2019-11-07
Decision date: 2020-04-02
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.