COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN— 510(k) K082012

Name: FDA 510(k) clearance K082012
Creator: U.S. Food and Drug Administration
Published: 2008-10-14

Substantially Equivalent

Cosman Medical, Inc.

FDA 510(k) clearance K082012 for COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN, Substantially Equivalent on 2008-10-14. Applicant: Cosman Medical, Inc.. Device class: 2.

Clearance details

Applicant: Cosman Medical, Inc.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2008-07-15
Decision date: 2008-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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.