510(k) K200630

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

K200630 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags". The FDA issued a decision of Substantially Equivalent on April 9, 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.