EnlightenVue Microendoscopy System

Laparoscope, General & Plastic Surgery

EnlightenVue, Inc.

The following data is part of a premarket notification filed by Enlightenvue, Inc. with the FDA for Enlightenvue Microendoscopy System.

Pre-market Notification Details

Device IDK192300
510k NumberK192300
Device Name:EnlightenVue Microendoscopy System
ClassificationLaparoscope, General & Plastic Surgery
Applicant EnlightenVue, Inc. 1111 Race Street, Suite 6a Denver,  CO  80206
ContactGiacomo Basadonna
CorrespondentGiacomo Basadonna
Alira Health 1111 Race Street Suite 6a Denver,  CO  80206
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2020-03-20

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