ARDO Bellis— 510(k) K230590

Substantially Equivalent

Ardo Medical AG

FDA 510(k) clearance K230590 for ARDO Bellis, Substantially Equivalent on 2023-03-30. Applicant: Ardo Medical AG.

Clearance details

Applicant: Ardo Medical AG
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2023-03-03
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Unteraegeri, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.