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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 K201884
Device Name ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
Applicant
Microline Surgical, Inc.
50 Dunham Rd., Suite 1500
Beverly,  MA  01915
Applicant Contact Scott Marchand Davis
Correspondent
Microline Surgical, Inc.
50 Dunham Rd., Suite 1500
Beverly,  MA  01915
Correspondent Contact Scott Marchand Davis
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/08/2020
Decision Date 10/21/2020
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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