K233140
- 510(k) number
- K233140
- Device name
- Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
- Applicant
- Hygea Medical Technology Co., Ltd. CN
- Product code
- NEY — System, Ablation, Microwave And Accessories
- Decision date
- 2024-01-31
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233140.pdf
Official FDA record: K233140
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.