Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)— 510(k) K233140

Substantially Equivalent

Hygea Medical Technology Co., Ltd.

FDA 510(k) clearance K233140 for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact), Substantially Equivalent on 2024-01-31. Applicant: Hygea Medical Technology Co., Ltd..

Clearance details

Applicant: Hygea Medical Technology Co., Ltd.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2023-09-27
Decision date: 2024-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.