MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM— 510(k) K123524

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K123524 for MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM, Substantially Equivalent on 2013-02-13. Applicant: Medtronic Neurosurgery.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code JXG
Advisory panel: Neurology
Date received: 2012-11-15
Decision date: 2013-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, 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.