DeviceClearance

K191357

Substantially Equivalent

Flexible HD Cysto-Urethroscope System

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
FAJ
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 FAJ

product code FAJ
Injury
533
Malfunction
6,705
Total
7,238

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.