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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K243820
Device Name Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
Applicant
Dornier Medtech America
1155 Roberts Blvd., Suite 100
Kennesaw,  GA  30144
Applicant Contact John Hoffer
Correspondent
Dornier Medtech America
1155 Roberts Blvd., Suite 100
Kennesaw,  GA  30144
Correspondent Contact John Hoffer
Regulation Number876.1500
Classification Product Code
FED  
Date Received12/12/2024
Decision Date 01/31/2025
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
Predetermined Change
Control Plan Authorized		 No
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