DeviceClearance

K201135

Substantially Equivalent

Image1 S CCU, Image1 S 4U Camera Head

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
FET
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Segundo, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET
Injury
313
Malfunction
54,276
Total
54,589

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.