POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB— 510(k) K031097

Substantially Equivalent

Sophysa SA

FDA 510(k) clearance K031097 for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB, Substantially Equivalent on 2004-02-26. Applicant: Sophysa SA.

Clearance details

Applicant: Sophysa SA
Product code: Code JXG
Advisory panel: Neurology
Date received: 2003-04-07
Decision date: 2004-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, 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.