FDA 510(k)

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags

K-Number: K200630 · 2020-04-09

Decision Date2020-04-09

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200630. 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 Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags?

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Medtronic, Inc.. The 510(k) number is K200630.

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

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200630.

Who is the listed applicant for Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags?

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 Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags?

The FDA product code for Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags is GWM.

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Official Source

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