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Uvision360, Inc.

FDA Regulatory Profile

Uvision360, Inc. has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jun 30, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K210512LUMINELLE DTx SystemJun 30, 2021
K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)Nov 1, 2019
K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidJun 6, 2019
K181909Luminelle DTx Hysteroscopy SystemAug 16, 2018

FDA data resources