Polaris RF Ablation System— 510(k) K181864

Substantially Equivalent

Baylis Medical Company, Inc.

FDA 510(k) clearance K181864 for Polaris RF Ablation System, Substantially Equivalent on 2019-01-02. Applicant: Baylis Medical Company, Inc..

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code GXD
Advisory panel: Neurology
Date received: 2018-07-12
Decision date: 2019-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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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.