Uvision360, Inc. - FDA 510(k) Cleared Devices
Recent clearances: LUMINELLE DTx System, Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic), Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Uvision360, Inc. Obstetrics & Gynecology ✕
4 devices
Cleared
Jun 30, 2021
LUMINELLE DTx System
Obstetrics & Gynecology
127d
Cleared
Nov 01, 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable...
Obstetrics & Gynecology
71d
Cleared
Jun 06, 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable...
Obstetrics & Gynecology
66d
Cleared
Aug 16, 2018
Luminelle DTx Hysteroscopy System
Obstetrics & Gynecology
30d