FDA.report

510(k) K260377

Device
XSense Cryoablation System with CryoProbes
Applicant
IceCure Medical , Ltd.
510(k) number
K260377
Product code
GEH
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-24
Date received
2026-02-05
Regulation
878.4350
Classification name
Unit, Cryosurgical, Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Maayan Levi
Address
7 Haeshel St. P.O.B 3163 Caesarea IL 3079504 3079504

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GEH

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K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH2026-04-22
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K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.2026-02-13
K251524Dr. Yglo Skin Tag RemoverTheotclab Healthcare B.V.2026-01-12
K250742Focused Cryotherapy SystemFocused Cryo, Inc.2025-12-09
K253114TargetCool™ (RM-DT02W)Recensmedical, Inc.2025-10-16
K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025-10-16
K253348TargetCool-eRecensmedical, Inc.2025-10-15
K252903Verruca-Freeze H PlusCryosurgery, Inc.2025-10-10
K251493Skin Clinic Freeze Point for Warts and Skin TagsCryoconcepts LP2025-05-22
K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025-04-15
K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025-03-13
K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.2025-01-29
K242288Advanced Cryo Wart RemoverMedical Brands Laboratories B.V.2025-01-21
K243454Verruca-Freeze HCryosurgery, Inc.2024-12-03