Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)— 510(k) K192278

Substantially Equivalent

Uvision360, Inc.

FDA 510(k) clearance K192278 for Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic), Substantially Equivalent on 2019-11-01. Applicant: Uvision360, Inc..

Clearance details

Applicant: Uvision360, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2019-08-22
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.