Encision AEM EnTouch 2X Scissor

Electrosurgical, Cutting & Coagulation & Accessories

Encision Inc.

The following data is part of a premarket notification filed by Encision Inc. with the FDA for Encision Aem Entouch 2x Scissor.

Pre-market Notification Details

Device IDK201018
510k NumberK201018
Device Name:Encision AEM EnTouch 2X Scissor
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Encision Inc. 6797 Winchester Circle Boulder,  CO  80260
ContactPete Geary
CorrespondentPete Geary
Encision Inc. 6797 Winchester Circle Boulder,  CO  80260
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-17
Decision Date2020-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10815288013997 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
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20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014014 K201018 000
20815288014007 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014014 K201018 000
20815288014007 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014007 K201018 000
20815288014014 K201018 000
20815288014021 K201018 000
10815288013997 K201018 000
20815288014021 K201018 000

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