Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
FDA 510(k) K200630 · Medtronic, Inc.
510(k) numberK200630
Submission
- Device name
- Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
- Applicant
- Medtronic, Inc.
Irvine, CA, US - Received
- March 10, 2020
- Decision date
- April 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional | Braincare Desenvolvimento E Inovação Tecnológica… | 07/18/2024SE |
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| K210993 | CereLink ICP MonitorGWM · Special | Integra Lifesciences Production Corporation | 04/30/2021SE |
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| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension CableGWM · Special | Integra Lifesciences Corp. | 01/11/2019SE |
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Questions and answers
When was Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags cleared by the FDA?
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630) received a 510(k) decision of Substantially Equivalent on April 9, 2020, 30 days after the submission was received.
What is the product code of K200630?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.