OPERA, OPERA eco— 510(k) K190810

Substantially Equivalent

Unimom.Co

FDA 510(k) clearance K190810 for OPERA, OPERA eco, Substantially Equivalent on 2019-08-30. Applicant: Unimom.Co.

Clearance details

Applicant: Unimom.Co
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2019-03-29
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osan-Si, KR

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.