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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K210394
Device Name Electrosurgical accessory
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 Number876.4300
Classification Product Code
FAS  
Date Received02/10/2021
Decision Date 05/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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