CLARUS PHOENIX ENDOSCOPE

Arthroscope

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Phoenix Endoscope.

Pre-market Notification Details

Device IDK940144
510k NumberK940144
Device Name:CLARUS PHOENIX ENDOSCOPE
ClassificationArthroscope
Applicant CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
ContactGregory J Mathison
CorrespondentGregory J Mathison
CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-11
Decision Date1995-04-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.