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

Clearance details

Applicant

Baylis Medical Co., Inc.

Product code

Code GXI

Device class

Class 2

Regulation

21 CFR 882.4725

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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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 →

• Z-2391-2016 — Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.Class II·Terminated·Halyard Health, Inc·20160616

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053082.