XSense Cryoablation System with CryoProbes

Q: What is the product code of K260377?

The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.

FDA 510(k) K260377 · IceCure Medical , Ltd.

Substantially Equivalent

510(k) numberK260377

Submission

Device name: XSense Cryoablation System with CryoProbes
Applicant: IceCure Medical , Ltd.
Caesarea, IL
Received: February 5, 2026
Decision date: February 24, 2026
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEH – Unit, Cryosurgical, Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4350
Specialty: General, Plastic Surgery

Other 510(k)s with product code GEH

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K262420	Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional	Serpex Medical	09/02/2026SE
K261068	Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional	Serpex Medical	06/30/2026SE
K261806	ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special	Erbe Elektromedizin GmbH	06/09/2026SE
K253230	ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional	Erbe Elektromedizin GmbH	04/22/2026SE
K252198	Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional	Medical Brands Laboratories B.V.	04/02/2026SE
K251928	CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional	Medinice S.A.	02/13/2026SE
K251524	Dr. Yglo Skin Tag RemoverGEH · Traditional	Theotclab Healthcare B.V.	01/12/2026SE
K250742	Focused Cryotherapy SystemGEH · Traditional	Focused Cryo, Inc.	12/09/2025SE
K253114	TargetCool (RM-DT02W)GEH · Special	Recensmedical, Inc.	10/16/2025SE
K253000	CryoFreeze Wart and Skin Tag RemoverGEH · Special	Cryosurgery, Inc.	10/16/2025SE

More from Cryosurgery, Inc.

510(k)	Device	Decision
K240892	XSense Cryoablation System with CryoprobesGEH · Traditional	06/28/2024SE
K183213	IceSense 3, ProSense, MultiSenseGEH · Traditional	12/20/2019SE
K102360	Icesence 3GEH · Traditional	11/29/2010SE

Questions and answers

When was XSense Cryoablation System with CryoProbes cleared by the FDA?

XSense Cryoablation System with CryoProbes (K260377) received a 510(k) decision of Substantially Equivalent on February 24, 2026, 19 days after the submission was received.

What is the product code of K260377?

The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.