FDA 510(k)

GEM FLOW COUPLER Monitor (GEM1020M-2)

K-Number: K213974 · 2022-04-20

ApplicantSynovis Micro Companies Alliance, Inc.

Decision Date2022-04-20

Product CodeDPW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GEM FLOW COUPLER Monitor (GEM1020M-2) is a medical device manufactured by Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2022-04-20 under approval number K213974. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM FLOW COUPLER Monitor (GEM1020M-2)?

GEM FLOW COUPLER Monitor (GEM1020M-2) is a medical device that received FDA 510(k) clearance on 2022-04-20. It is manufactured by Synovis Micro Companies Alliance, Inc.. The 510(k) number is K213974.

When was GEM FLOW COUPLER Monitor (GEM1020M-2) approved by the FDA?

GEM FLOW COUPLER Monitor (GEM1020M-2) received FDA 510(k) clearance on 2022-04-20, under approval number K213974.

What company makes GEM FLOW COUPLER Monitor (GEM1020M-2)?

GEM FLOW COUPLER Monitor (GEM1020M-2) is manufactured by Synovis Micro Companies Alliance, Inc..

What is the FDA product code for GEM FLOW COUPLER Monitor (GEM1020M-2)?

The FDA product code for GEM FLOW COUPLER Monitor (GEM1020M-2) is DPW.

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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.