CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE— 510(k) K922936

Substantially Equivalent

Clinical Neuro Systems, LLC

FDA 510(k) clearance K922936 for CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE, Substantially Equivalent on 1992-08-26. Applicant: Clinical Neuro Systems, LLC.

Clearance details

Applicant: Clinical Neuro Systems, LLC
Product code: Code JXG
Advisory panel: Neurology
Date received: 1992-06-18
Decision date: 1992-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.