K240978

Substantially Equivalent

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

Applicant: MacroLux Medical Technology Co., Ltd.
Product code: HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2024-04-10
Decision date: 2024-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.