ICEfx Cryoablation System (FPRCH8000-02)
FDA 510(k) clearance K234002 · decided 2024-03-13
Clearance details
- K-number
- K234002
- Device name
- ICEfx Cryoablation System (FPRCH8000-02)
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-12-19
- Decision date
- 2024-03-13
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Number recall (Z-2550-2025) | Boston Scientific Corporation | 2025-09-11 |
| Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 recall (Z-2551-2025) | Boston Scientific Corporation | 2025-09-11 |