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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 K161086
Device Name Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
Applicant
Sterilmed, Inc.
5010 Cheshire Pkwy.
Suite 2
Plymouth,  MN  55446
Applicant Contact Patricia Kaufman
Correspondent
Sterilmed, Inc.
5010 Cheshire Pkwy.
Suite 2
Plymouth,  MN  55446
Correspondent Contact Neelu Gibson
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received04/18/2016
Decision Date 09/20/2016
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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