DeviceClearance

K911492

Substantially Equivalent

ENDOSCOPIC LIGHT SOURCE

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

Adverse events under product code GCT

product code GCT
Malfunction
1,393
Other
2
Total
1,395

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.