External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters— 510(k) K242974

Substantially Equivalent

Sophysa

FDA 510(k) clearance K242974 for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters, Substantially Equivalent on 2025-06-20. Applicant: Sophysa.

Clearance details

Applicant: Sophysa
Product code: Code JXG
Advisory panel: Neurology
Date received: 2024-09-26
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orsay, FR

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.