DeviceClearance

K883694

Substantially Equivalent

TENSIOMETER

Applicant
W. L. Gore & Associates, Inc.
Product code
LXH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Flagstaff, AZ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LXH

product code LXH
Death
11
Injury
2,218
Malfunction
31,318
Total
33,547

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.