XSense Cryoablation System with CryoProbes— 510(k) K260377
Substantially EquivalentIceCure Medical , Ltd.
FDA 510(k) clearance K260377 for XSense Cryoablation System with CryoProbes, Substantially Equivalent on 2026-02-24. Applicant: IceCure Medical , Ltd.. Device class: 2.
Summary
IceCure Medical's XSense Cryoablation System with CryoProbes is filed under product code GEH (Unit, Cryosurgical, Accessories). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 878.4350. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
IceCure Medical filed from Caesarea, Israel. The decision came 19 calendar days after FDA received it (February 5 to February 24, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- IceCure Medical , Ltd.
- Product code
- Product code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Caesarea, IL
Recent devices under product code GEH
view all- K260520 — Skin Clinic Nitro Clear for Warts and Skin Tags
- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
More clearances from IceCure Medical , Ltd.
view allAdverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.