Luminelle DTx Hysteroscopy System

Cystoscope And Accessories, Flexible/rigid

UVision360 Inc.

The following data is part of a premarket notification filed by Uvision360 Inc. with the FDA for Luminelle Dtx Hysteroscopy System.

Pre-market Notification Details

Device IDK181909
510k NumberK181909
Device Name:Luminelle DTx Hysteroscopy System
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant UVision360 Inc. 4441-106 Six Forks Road, #179 Raleigh,  NC  27609
ContactAllison London Brown
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-07-17
Decision Date2018-08-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853227708040 K181909 000
00853277008015 K181909 000
00853277008022 K181909 000
00853277008039 K181909 000
00853277008046 K181909 000
00853227708002 K181909 000
00853227708019 K181909 000
00853227708026 K181909 000
00853227708033 K181909 000
00853277008008 K181909 000

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