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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K140923
Device Name TRACTION POLYPECTOMY SNARE
Applicant
OVESCO ENDOSCOPY AG
DORFACKERSTRASSE 26
TUEBINGEN, BADEN-WUERTTEMBERG,  DE 72074
Applicant Contact TANJA LINZER
Correspondent
OVESCO ENDOSCOPY AG
DORFACKERSTRASSE 26
TUEBINGEN, BADEN-WUERTTEMBERG,  DE 72074
Correspondent Contact TANJA LINZER
Regulation Number876.4300
Classification Product Code
FDI  
Date Received04/10/2014
Decision Date 11/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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