BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.— 510(k) K862303

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K862303 for BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH., Substantially Equivalent on 1986-08-12. Applicant: Pudenz-Schulte Medical Research Corp..

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code JXG
Advisory panel: Neurology
Date received: 1986-06-17
Decision date: 1986-08-12
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.