BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6— 510(k) K053082

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K053082 for BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6, Substantially Equivalent on 2005-11-30. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2005-11-02
Decision date: 2005-11-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, Ontario, CA

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.