CODMAN-MEDOS VALVE SHUNT SYSTEM— 510(k) K944222

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K944222 for CODMAN-MEDOS VALVE SHUNT SYSTEM, Substantially Equivalent on 1995-07-28. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code JXG
Advisory panel: Neurology
Date received: 1994-08-30
Decision date: 1995-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, 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.