EQUI-FLOW VALVE AND SHUNT SYSTEM— 510(k) K042558

Substantially Equivalent

Integra Neurosciences Implants S.A.

FDA 510(k) clearance K042558 for EQUI-FLOW VALVE AND SHUNT SYSTEM, Substantially Equivalent on 2004-10-06. Applicant: Integra Neurosciences Implants S.A..

Clearance details

Applicant: Integra Neurosciences Implants S.A.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2004-09-21
Decision date: 2004-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, 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.