K190827

Substantially Equivalent

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

Applicant: Uvision360, Inc.
Product code: HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2019-04-01
Decision date: 2019-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, US

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.