Canady Plasma SMART XL-1000 Electrosurgical Generator With Accessories

Electrosurgical, Cutting & Coagulation & Accessories

US Medical Innovations, LLC

The following data is part of a premarket notification filed by Us Medical Innovations, Llc with the FDA for Canady Plasma Smart Xl-1000 Electrosurgical Generator With Accessories.

Pre-market Notification Details

Device IDK192124
501k NumberK192124
Device Name:Canady Plasma SMART XL-1000 Electrosurgical Generator With Accessories
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant US Medical Innovations, LLC 6930 Carroll Ave Takoma Park,  MD  20912
ContactDavid Hinds
CorrespondentTim Joiner
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2019-11-21

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