K232241
- 510(k) number
- K232241
- Device name
- Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
- Applicant
- Betters(Suzhou) Medical Co., Ltd. CN
- Product code
- NEY — System, Ablation, Microwave And Accessories
- Decision date
- 2023-11-13
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232241.pdf
Official FDA record: K232241
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.