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510(k) K111165

KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE by KARL STORZ Endoscopy-America, Inc. — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2012
Date Received
April 26, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Central Control Unit
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

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