DeviceClearance

K233630

Substantially Equivalent

Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2

Applicant
Ambu A/S
Product code
FGB
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ballerup, DK
Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB
Death
6
Injury
552
Malfunction
3,922
Other
1
Total
4,481

Source: openFDA MAUDE database, through . 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.