DeviceClearance

K953484

Substantially Equivalent

POLLUX OA/POLLUX 30A/POLLUX 70A

Applicant
Pollux Endoscopy, Inc.
Product code
HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunrise, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

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.