DeviceClearance

K251731

Substantially Equivalent

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

Applicant
Karl Storz SE & CO. KG
Product code
EOQ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Tuttlingen, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

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.