FDA 510(k)

Luminelle DTx Hysteroscopy System

K-Number: K181909 · 2018-08-16

Decision Date2018-08-16

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Luminelle DTx Hysteroscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Uvision360, Inc.. It received FDA 510(k) clearance on 2018-08-16 under 510(k) 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. The listed applicant is Uvision360, Inc.. The 510(k) number is K181909.

When did Luminelle DTx Hysteroscopy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Luminelle DTx Hysteroscopy System?

The FDA 510(k) record lists Uvision360, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Other records listing Uvision360, Inc. as applicant

K210512LUMINELLE DTx 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)

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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.