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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 K182013
Device Name EasyInstruments
Applicant
Agency For Medical Innovations GmbH
Im Letten 1
Feldkirch,  AT 6800
Applicant Contact Martin Hohlrieder
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Pierre Bounaud
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/27/2018
Decision Date 03/11/2019
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
Predetermined Change
Control Plan Authorized		 No
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