AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007— 510(k) K003978

Substantially Equivalent

Afx, Inc.

FDA 510(k) clearance K003978 for AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007, Substantially Equivalent on 2001-05-22. Applicant: Afx, Inc..

Clearance details

Applicant: Afx, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2000-12-22
Decision date: 2001-05-22
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.