Synergy Gold (SG) Portable (Models MM011450 and MM011460)— 510(k) K210124

Substantially Equivalent

Uzinmedicare Co.

FDA 510(k) clearance K210124 for Synergy Gold (SG) Portable (Models MM011450 and MM011460), Substantially Equivalent on 2021-10-19. Applicant: Uzinmedicare Co..

Clearance details

Applicant: Uzinmedicare Co.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2021-01-19
Decision date: 2021-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-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.