Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
FDA 510(k) K201118 · Medtronic, Inc.
510(k) numberK201118
Submission
- Device name
- Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
- Applicant
- Medtronic, Inc.
Irvine, CA, US - Received
- April 27, 2020
- Decision date
- May 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level cleared by the FDA?
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (K201118) received a 510(k) decision of Substantially Equivalent on May 26, 2020, 29 days after the submission was received.
What is the product code of K201118?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.