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 IDK221235
510k NumberK221235
Device Name:NeXus Ultrasonic Surgical Aspirator System
ClassificationInstrument, Ultrasonic Surgical
Applicant Misonix Inc. 1938 New Highway Farmingdale,  NY  11735
ContactJohn Salerno
CorrespondentJohn Salerno
Misonix 1938 New Highway Farmingdale,  NY  11735
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-29
Decision Date2022-07-28

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