DeviceClearance

K001362

Substantially Equivalent

KARL STORZ 3D VIDEO SYSTEM

Applicant
Karl Storz Imaging, Inc.
Product code
GCI
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Goleta, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GCI

product code GCI
Malfunction
635
Total
635

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.