DeviceClearance

K160044

Substantially Equivalent

Image1 SPIES System

Applicant
Karl Storz Endoscopy America, Inc.
Product code
FET
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
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.