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FDA 510(k)

Luminelle DTx Hysteroscopy System

K-Number: K181909 · 2018-08-16

ApplicantUvision360, Inc.
Decision Date2018-08-16
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Luminelle DTx Hysteroscopy System is a medical device manufactured by Uvision360, Inc.. It received FDA 510(k) clearance on 2018-08-16 under approval number K181909. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luminelle DTx Hysteroscopy System?

Luminelle DTx Hysteroscopy System is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Uvision360, Inc.. The 510(k) number is K181909.

When was Luminelle DTx Hysteroscopy System approved by the FDA?

Luminelle DTx Hysteroscopy System received FDA 510(k) clearance on 2018-08-16, under approval number K181909.

What company makes Luminelle DTx Hysteroscopy System?

Luminelle DTx Hysteroscopy System is manufactured by Uvision360, Inc..

What is the FDA product code for Luminelle DTx Hysteroscopy System?

The FDA product code for Luminelle DTx Hysteroscopy System is FAJ.

Related Clinical Trials

NCT07518693 Clinical Observation of Hysteroscopy-Assisted Placement of Handmade Frameless GyneFix-LNG-IUS (Retrospective Cohort) COMPLETED

Other Devices by Uvision360, Inc.

K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid K210512LUMINELLE DTx System

Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. K182876Uro-N CystoscopeUroviu Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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