K243042

Substantially Equivalent

Co-Ablation System with Sterile Co-Ablation Probe

Applicant: Hygea Medical Technology Co., Ltd.
Product 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

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.