FLEX Microwave Ablation System and Accessories— 510(k) K163118

Substantially Equivalent

Neuwave Medical, Inc.

FDA 510(k) clearance K163118 for FLEX Microwave Ablation System and Accessories, Substantially Equivalent on 2017-03-09. Applicant: Neuwave Medical, Inc..

Clearance details

Applicant: Neuwave Medical, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2016-11-08
Decision date: 2017-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madision, WI, 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.