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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 K213610
Device Name Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
Applicant
Katalyst Surgical, LLC
754 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact Liz Morgan
Correspondent
Katalyst Surgical, LLC
754 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact Liz Morgan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/15/2021
Decision Date 10/07/2022
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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