Ambu aScope 4 Cysto— 510(k) K193095

Clearance details

Applicant

Ambu A/S

Product code

Code FAJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2019-11-07

Decision date

2020-04-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ballerup, DK

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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 →