Co-Ablation System with Sterile Co-Ablation Probe— 510(k) K243042

Substantially Equivalent

Hygea Medical Technology Co., Ltd.

FDA 510(k) clearance K243042 for Co-Ablation System with Sterile Co-Ablation Probe, Substantially Equivalent on 2025-01-29. Applicant: Hygea Medical Technology Co., Ltd..

Clearance details

Applicant: Hygea Medical Technology Co., Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2024-09-27
Decision date: 2025-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.