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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 K212107
Device Name Reverso
Applicant
Intelis Instruments , Ltd.
Haoman 12
Hadera,  IL 3850172
Applicant Contact Amit Goren
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
18 Hata'As St.
Suite 21
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/06/2021
Decision Date 11/10/2021
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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