CLARUS ENDOSCOPIC BALL PROBE

Instrument, Microsurgical

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 Ball Probe.

Pre-market Notification Details

Device IDK926048
510k NumberK926048
Device Name:CLARUS ENDOSCOPIC BALL PROBE
ClassificationInstrument, Microsurgical
Applicant CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis,  MN  55447
ContactGregory J Mathison
CorrespondentGregory J Mathison
CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis,  MN  55447
Product CodeGZX  
CFR Regulation Number882.4525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-01
Decision Date1993-04-07

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