510(k) K234002 ยท GEH Unit, Cryosurgical, Accessories
ICEfx Cryoablation System (FPRCH8000-02)
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Mar 13, 2024 |
| Received | Dec 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2025 | Boston Scientific Corporation ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 Open, Classified |
GEH | None listed |
| Sep 11, 2025 | Boston Scientific Corporation Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 Open, Classified |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.