FDA 510(k)

Becker External Drainage and Monitoring System

K-Number: K200456 · 2020-03-26

Decision Date2020-03-26

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Becker External Drainage and Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K200456. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Becker External Drainage and Monitoring System?

Becker External Drainage and Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Medtronic, Inc.. The 510(k) number is K200456.

When did Becker External Drainage and Monitoring System receive FDA 510(k) clearance?

Becker External Drainage and Monitoring System received FDA 510(k) clearance on 2020-03-26, under 510(k) number K200456.

Who is the listed applicant for Becker External Drainage and Monitoring System?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Becker External Drainage and Monitoring System?

The FDA product code for Becker External Drainage and Monitoring System is GWM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.