510(k) K201118

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level by Medtronic, Inc. — Product Code GWM

K201118 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level". The FDA issued a decision of Substantially Equivalent on May 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.