NeXus Ultrasonic Surgical Aspirator System

Instrument, Ultrasonic Surgical

Misonix, Inc.

The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Nexus Ultrasonic Surgical Aspirator System.

Pre-market Notification Details

Device IDK190160
510k NumberK190160
Device Name:NeXus Ultrasonic Surgical Aspirator System
ClassificationInstrument, Ultrasonic Surgical
Applicant Misonix, Inc. 1938 New Highway Farmingdale,  NY  11735
ContactJohn Salerno
CorrespondentJohn Salerno
Misonix, Inc. 1938 New Highway Farmingdale,  NY  11735
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-30
Decision Date2019-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00841626103535 K190160 000

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