DeviceClearance

K993103

Substantially Equivalent

ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES

Applicant
Richard Wolf Medical Instruments Corp.
Product code
GCM
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Vernon Hills, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GCM

product code GCM
Malfunction
1,233
Total
1,233

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.