K234002 is an FDA 510(k) clearance for the ICEfx Cryoablation System (FPRCH8000-02). This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 13, 2024, 85 days after receiving the submission on December 19, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K234002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2023 |
| Decision Date | March 13, 2024 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |