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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K123172
Device Name KOGENT BIPOLAR FORCEPS
Applicant
Katalyst Surgical, LLC
754 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact MONA DEAN
Correspondent
Katalyst Surgical, LLC
754 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact MONA DEAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/09/2012
Decision Date 12/21/2012
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
Predetermined Change
Control Plan Authorized		 No
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