Kogent Torus Ultrasonic Aspirator

Instrument, Ultrasonic Surgical

Katalyst Surgical, LLC

The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Kogent Torus Ultrasonic Aspirator.

Pre-market Notification Details

Device IDK192963
510k NumberK192963
Device Name:Kogent Torus Ultrasonic Aspirator
ClassificationInstrument, Ultrasonic Surgical
Applicant Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield,  MO  63005
ContactMeryl Koch Wilhelm
CorrespondentMeryl Koch Wilhelm
Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield,  MO  63005
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2020-06-19

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