CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM— 510(k) K112156

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K112156 for CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM, Substantially Equivalent on 2011-10-17. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code JXG
Advisory panel: Neurology
Date received: 2011-07-27
Decision date: 2011-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, 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.