K201293

Substantially Equivalent

Ureterorenoscope System

Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
Product code
FGB
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Shanghai, CN
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.