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XSense Cryoablation System

FDA UDI

Class II (US FDA UDI)

by Icecure Medical Ltd

Identity

Trade Name
XSense Cryoablation System FDA UDI
Generic Name
General cryosurgical system, cryogen gas, electronic FDA UDI
Model / Reference
CSS-2004054 FDA UDI

Identifiers

Primary DI / UDI-DI
07290015487511 FDA UDI
510(k) Number
K240892 FDA UDI
FDA Product Code
GEH FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Weight — 83 Kilogram FDA UDI
Height — 162 Centimeter FDA UDI
Depth — 56 Centimeter FDA UDI
Width — 46 Centimeter FDA UDI

Category: General cryosurgical system, cryogen gas, electronic

XSense Cryoablation System by Icecure Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, electronic.

Cleared under the same submission

K240892 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icecure Medical Ltd

Sources (1)

  • FDA UDI 1aa42e3c-971f-4c01-9d00-c7f95841a654 36 fields · synced May 30, 2026