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FDA 510(k)

LUMINELLE DTx System

K-Number: K210512 · 2021-06-30

ApplicantUvision360, Inc.
Decision Date2021-06-30
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUMINELLE DTx System is a medical device manufactured by Uvision360, Inc.. It received FDA 510(k) clearance on 2021-06-30 under approval number K210512. 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 System?

LUMINELLE DTx System is a medical device that received FDA 510(k) clearance on 2021-06-30. It is manufactured by Uvision360, Inc.. The 510(k) number is K210512.

When was LUMINELLE DTx System approved by the FDA?

LUMINELLE DTx System received FDA 510(k) clearance on 2021-06-30, under approval number K210512.

What company makes LUMINELLE DTx System?

LUMINELLE DTx System is manufactured by Uvision360, Inc..

What is the FDA product code for LUMINELLE DTx System?

The FDA product code for LUMINELLE DTx System is FAJ.

Other Devices by Uvision360, Inc.

K181909Luminelle DTx Hysteroscopy System K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

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 K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

Official Source

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

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