510(k) K113062

ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES by Endoservice Optical Instruments GmbH — Product Code FBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2012
Date Received
October 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Telescope, Rigid, Endoscopic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type