AveCure BT Microwave Ablation System— 510(k) K192406

Substantially Equivalent

Medwaves, Inc.

FDA 510(k) clearance K192406 for AveCure BT Microwave Ablation System, Substantially Equivalent on 2020-11-25. Applicant: Medwaves, Inc..

Clearance details

Applicant: Medwaves, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2019-09-04
Decision date: 2020-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.