EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS— 510(k) K972994

Substantially Equivalent

Integra Neurocare, LLC

FDA 510(k) clearance K972994 for EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS, Substantially Equivalent on 1997-11-03. Applicant: Integra Neurocare, LLC.

Clearance details

Applicant: Integra Neurocare, LLC
Product code: Code JXG
Advisory panel: Neurology
Date received: 1997-08-12
Decision date: 1997-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Prairie, WI, US

Download summary PDF View on FDA.gov ↗

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.