MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM— 510(k) K040201

Name: FDA 510(k) clearance K040201
Creator: U.S. Food and Drug Administration
Published: 2004-02-26

Substantially Equivalent

Integra Neurosciences Implants S.A.

FDA 510(k) clearance K040201 for MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM, Substantially Equivalent on 2004-02-26. Applicant: Integra Neurosciences Implants S.A.. Device class: 2.

Clearance details

Applicant: Integra Neurosciences Implants S.A.
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2004-01-29
Decision date: 2004-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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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.