DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20— 510(k) K101372

Name: FDA 510(k) clearance K101372
Creator: U.S. Food and Drug Administration
Published: 2010-08-10

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K101372 for DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20, Substantially Equivalent on 2010-08-10. Applicant: Baylis Medical Co., Inc.. Device class: 2.

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: 2010-05-17
Decision date: 2010-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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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.