FDA.reportPublic FDA data

XSense Cryoablation System

Primary DI
07290015487511
Brand
XSense Cryoablation System
Company
ICECURE MEDICAL LTD
Model
CSS-2004054
Published
2025-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240892000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240892000XSense Cryoablation System with CryoprobesIceCure Medical , Ltd.2024-06-28GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015487511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015487511072900154875117290015487511

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, electronicAn assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth56Centimeter
Height162Centimeter
Weight83Kilogram
Width46Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 millibar1000 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18889025716icecuresupport@icecure-medical.com

Regulatory Flags#

DUNS number
514758619
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015487290PROSENSE™ SYSTEM 100-127 VACFAS3000000-2FAS3000000-22021-08-11
07290015487160PROSENSE™ SYSTEM 100-127 VACFAS3000000FAS30000002019-10-24
07290015487061Temperature SensorFAT8000000FAT80000002022-06-07
07290015487542Cryoprobe CP-20040592025-05-06
07290015487535CryoprobeCP-20040582025-05-06
17290015487549Cryoprobe CP-20040592025-05-06
07290015487528External 25L DewarCSS-20040552025-05-05
07290015487115Introducer D2.5 mm, 115 mm, Trocar. FAC9000000FAC90000002019-10-24
07290015487122Introducer D3.5 mm, 122 mm, Trocar. FAC9100000FAC91000002019-10-24
07290015487139Introducer D3.5 mm, 167 mm, Trocar. FAC9200000FAC92000002019-10-24
07290015487023Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric.FAP7100000FAP71000002019-10-24
07290015487030Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic.FAP7200000FAP72000002019-10-24
07290015487047Cryoprobe D2.4 mm/13G, 124 mm, Trocar, Spheric.FAP7600000FAP76000002019-10-24
07290015487054Cryoprobe D2.4 mm/13G, 134 mm, Trocar, Elliptic.FAP7800000FAP78000002019-10-24
07290015487085Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic.FAP7410000FAP74100002019-10-24
07290015487153HolderFAG3000000FAG30000002023-01-19
07290015487092Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic.FAP7400000FAP74000002019-10-24
07290015487078Cryoprobe D2.4 mm/13G, 180 mm, Trocar, Elliptic.FAP7820000FAP78200002019-10-24
07290015487108Cryoprobe D3.4 mm/10G, 285 mm, Pencil, Elliptic.FAP7910000FAP79100002019-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28