DeviceClearance

K053262

Substantially Equivalent

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
ERL
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Culver City, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL
Malfunction
11,234
Total
11,234

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.