P-S MEDICAL CSF-FLOW CONTROL VALVE-— 510(k) K841442

Substantially Equivalent

P-S Medical

FDA 510(k) clearance K841442 for P-S MEDICAL CSF-FLOW CONTROL VALVE-, Substantially Equivalent on 1984-04-19. Applicant: P-S Medical.

Clearance details

Applicant: P-S Medical
Product code: Code JXG
Advisory panel: Neurology
Date received: 1984-04-06
Decision date: 1984-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.