510(k) K190827

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid by Uvision360, Inc. — Product Code HIH

K190827 is an FDA 510(k) premarket notification submitted by Uvision360, Inc. for the device "Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid". The FDA issued a decision of Substantially Equivalent on Jun 6, 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.