DeviceClearance

K081729

Substantially Equivalent

MODIFICATION TO GFX NERVE ABLATION SYSTEM

Applicant
Bioform Medical, Inc.
Product code
GXD
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Franksville, WI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GXD

product code GXD
Injury
228
Total
228

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.