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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, anastomotic, microvascular
510(k) Number K191252
Device Name Gem FlowCoupler System
Applicant
Baxter/ Synovis Micro Companies Alliance Inc.
2875 University Ave. West
St. Paul,  MN  55114
Applicant Contact Julie Carlston
Correspondent
Baxter/ Synovis Micro Companies Alliance Inc.
2875 University Ave. West
St. Paul,  MN  55114
Correspondent Contact Julie Carlston
Regulation Number878.4300
Classification Product Code
MVR  
Subsequent Product Code
DPW  
Date Received05/09/2019
Decision Date 07/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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