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510(k) K133736

ENDOSCOPIC SUTURE CUTTER by United States Endoscopy Group, Inc. — Product Code OCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2014
Date Received
December 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

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