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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 K201018
Device Name Encision AEM enTouch 2X Scissor
Applicant
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80260
Applicant Contact Pete Geary
Correspondent
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80260
Correspondent Contact Pete Geary
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/17/2020
Decision Date 07/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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