FDA 510(k)

ICEfx Cryoablation System (FPRCH8000-02)

K-Number: K234002 · 2024-03-13

Decision Date2024-03-13

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ICEfx Cryoablation System (FPRCH8000-02) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K234002. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEfx Cryoablation System (FPRCH8000-02)?

ICEfx Cryoablation System (FPRCH8000-02) is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Boston Scientific. The 510(k) number is K234002.

When did ICEfx Cryoablation System (FPRCH8000-02) receive FDA 510(k) clearance?

ICEfx Cryoablation System (FPRCH8000-02) received FDA 510(k) clearance on 2024-03-13, under 510(k) number K234002.

Who is the listed applicant for ICEfx Cryoablation System (FPRCH8000-02)?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICEfx Cryoablation System (FPRCH8000-02)?

The FDA product code for ICEfx Cryoablation System (FPRCH8000-02) is GEH.

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Related Devices (Code: GEH)

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.