Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide

Instrument, Ultrasonic Surgical

Covidien, Llc

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide.

Pre-market Notification Details

Device IDK180149
510k NumberK180149
Device Name:Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
ClassificationInstrument, Ultrasonic Surgical
Applicant Covidien, Llc 5920 Longbow Drive Boulder,  CO  80301
ContactNancy Sauer
CorrespondentNancy Sauer
Covidien, Llc 5920 Longbow Drive Boulder,  CO  80301
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-19
Decision Date2018-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521592865 K180149 000
10884521592896 K180149 000
10884521592889 K180149 000
20884521592855 K180149 000
20884521592848 K180149 000
20884521592831 K180149 000
20884521592824 K180149 000
10884521781627 K180149 000
20884521592909 K180149 000

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