POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400— 510(k) K042481

Substantially Equivalent

Sophysa SA

FDA 510(k) clearance K042481 for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400, Substantially Equivalent on 2004-12-14. Applicant: Sophysa SA.

Clearance details

Applicant: Sophysa SA
Product code: Code JXG
Advisory panel: Neurology
Date received: 2004-09-13
Decision date: 2004-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, 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.