K190174

Substantially Equivalent

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

Applicant: Aesculap, Inc.
Product code: JXG
Advisory panel: Neurology
Date received: 2019-02-01
Decision date: 2019-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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.