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510(k) DEN160014

remOVE System by Ovesco Endoscopy AG — Product Code QAG

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 22, 2017
Date Received
April 11, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Electrosurgical Clip Cutting System
Device Class
Class II
Regulation Number
876.4310
Review Panel
GU
Submission Type

To fragment metallic clips and remove them from the digestive tract.

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