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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 the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2022-04-20 under 510(k) 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. The listed applicant is Synovis Micro Companies Alliance, Inc.. The 510(k) number is K213974.

When did GEM FLOW COUPLER Monitor (GEM1020M-2) receive FDA 510(k) clearance?

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

Who is the listed applicant for GEM FLOW COUPLER Monitor (GEM1020M-2)?

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

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.

Other records listing Synovis Micro Companies Alliance, Inc. as applicant

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Official Source

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