MODIFICATION TO GFX NERVE ABLATION SYSTEM— 510(k) K081729

Substantially Equivalent

Bioform Medical, Inc.

FDA 510(k) clearance K081729 for MODIFICATION TO GFX NERVE ABLATION SYSTEM, Substantially Equivalent on 2008-08-07. Applicant: Bioform Medical, Inc..

Clearance details

Applicant: Bioform Medical, Inc.
Product code: Code GXD
Advisory panel: Neurology
Date received: 2008-06-18
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Franksville, WI, US

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Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.