Encision AEM Monopolar Laparoscopic Instruments And Accessories

Electrosurgical, Cutting & Coagulation & Accessories

Encision Incorporated

The following data is part of a premarket notification filed by Encision Incorporated with the FDA for Encision Aem Monopolar Laparoscopic Instruments And Accessories.

Pre-market Notification Details

Device IDK191612
510k NumberK191612
Device Name:Encision AEM Monopolar Laparoscopic Instruments And Accessories
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Encision Incorporated 6797 Winchester Circle Boulder,  CO  80301
ContactDenise Baker
CorrespondentCharles M. (mike) Hart
HART Consulting LLC 615 Reid Place Castle Rock,  CO  80108
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-17
Decision Date2020-03-20

NIH GUDID Devices

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