FDA 510(k)

Gem FlowCoupler System

K-Number: K190499 · 2019-09-06

ApplicantBaxter/ Synovis Micro Companies Alliance, Inc.

Decision Date2019-09-06

Product CodeMVR

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Gem FlowCoupler System is the device name listed in this FDA 510(k) record. The listed applicant is Baxter/ Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K190499. The device is classified under product code MVR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gem FlowCoupler System?

Gem FlowCoupler System is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Baxter/ Synovis Micro Companies Alliance, Inc.. The 510(k) number is K190499.

When did Gem FlowCoupler System receive FDA 510(k) clearance?

Gem FlowCoupler System received FDA 510(k) clearance on 2019-09-06, under 510(k) number K190499.

Who is the listed applicant for Gem FlowCoupler System?

The FDA 510(k) record lists Baxter/ 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 FlowCoupler System?

The FDA product code for Gem FlowCoupler System is MVR.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191252Gem FlowCoupler System

Related Devices (Code: MVR)

K191252Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.

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.