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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K213252
Device Name Dornier Thulio
Applicant
Dornier Medtech America, Inc.
1155 Roberts Blvd., Suite 100
Kennesaw,  GA  30144
Applicant Contact John Hoffer
Correspondent
Dornier Medtech America, Inc.
1155 Roberts Blvd., Suite 100
Kennesaw,  GA  30144
Correspondent Contact John Hoffer
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2021
Decision Date 07/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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