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

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..

Clearance details

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

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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.