K234002
- 510(k) number
- K234002
- Device name
- ICEfx Cryoablation System (FPRCH8000-02)
- Applicant
- Boston Scientific MN · US
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2024-03-13
- Date received
- 2023-12-19
- 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: K234002.pdf
Official FDA record: K234002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.