PS MEDICAL CSF-ACCESS DEVICE— 510(k) K913412

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K913412 for PS MEDICAL CSF-ACCESS DEVICE, Substantially Equivalent on 1993-03-30. Applicant: Pudenz-Schulte Medical Research Corp..

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code JXG
Advisory panel: Neurology
Date received: 1991-07-31
Decision date: 1993-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, 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.