DeviceClearance

K173650

Substantially Equivalent

AquaShield System CO2- Fujifilm

Applicant
United States Endoscopy Group, Inc.
Product code
FEQ
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mentor, OH, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FEQ

product code FEQ
Malfunction
1,135
Total
1,135

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.