CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR

Endoscope, Neurological

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Endoscopic Neurological Tissue Elevator.

Pre-market Notification Details

Device IDK942413
510k NumberK942413
Device Name:CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR
ClassificationEndoscope, Neurological
Applicant CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
ContactJohn V Hoek
CorrespondentJohn V Hoek
CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-20
Decision Date1994-11-22

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