510(k) K192278

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) by Uvision360, Inc. — Product Code HIH

K192278 is an FDA 510(k) premarket notification submitted by Uvision360, Inc. for the device "Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)". The FDA issued a decision of Substantially Equivalent on Nov 1, 2019. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Uvision360, Inc. has 3 other 510(k) clearances on record.