510(k) K200456

Becker External Drainage and Monitoring System by Medtronic, Inc. — Product Code GWM

K200456 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Becker External Drainage and Monitoring System". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Medtronic, Inc. has at least 10 other 510(k) clearances on record.