FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM— 510(k) K013946

Substantially Equivalent

Afx, Inc.

FDA 510(k) clearance K013946 for FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM, Substantially Equivalent on 2002-02-27. Applicant: Afx, Inc..

Clearance details

Applicant: Afx, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2001-11-29
Decision date: 2002-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.