K231661
- 510(k) number
- K231661
- Device name
- CryoThin Surgical System and Accessories
- Applicant
- Medinux (Tianjin) Technologies Co., Ltd. CN
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2023-11-27
- Date received
- 2023-06-07
- 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: K231661.pdf
Official FDA record: K231661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.