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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, Laparoscopic & Endoscopic, Reprocessed
510(k) Number K211203
Device Name Green OR Reprocessed Aquamantys Bipolar Sealer
Applicant
Green Or, LLC
4200 Dahlberg Dr. #300
Golden Valley,  MN  55422
Applicant Contact John Zehren
Correspondent
Pathway, LLC
8779 Cottonwood Ave. Suite 105
Santee,  CA  92071
Correspondent Contact Aaron Rogers
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received04/22/2021
Decision Date 04/07/2022
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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