FDA.reportPublic FDA data

PROSENSE™ SYSTEM 100-127 VAC

Primary DI
07290015487160
Brand
PROSENSE™ SYSTEM 100-127 VAC
Company
ICECURE MEDICAL LTD
Model
FAS3000000
Catalog number
FAS3000000
Published
2019-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories
QXWCryoablation Device For Local Treatment Of Low-Risk Breast Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2
QXWCryoablation Device For Local Treatment Of Low-Risk Breast CancerGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220077000
K102360000
K183213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220077000ProSense™ SystemIcecure Medical2025-10-03QXW
K102360000ICESENCE 3IceCure Medical , Ltd.2010-11-29GEH
K183213000IceSense 3, ProSense, MultiSenseIceCure Medical , Ltd.2019-12-20GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015487160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015487160072900154871607290015487160

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth27.56Inch
Height47.24Inch
Weight150Kilogram
Width19.68Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure32 Degrees Fahrenheit158 Degrees Fahrenheit
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Special Storage Condition, Specify00Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16468443066icecuresupport@icecure-medical.com
18889025716icecuresupport@icecure-medical.com

Regulatory Flags#

DUNS number
514758619
Device count
1
DM exempt
true
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
07290015487061Temperature SensorFAT8000000FAT80000002022-06-07
07290015487542Cryoprobe CP-20040592025-05-06
07290015487535CryoprobeCP-20040582025-05-06
17290015487549Cryoprobe CP-20040592025-05-06
07290015487511XSense Cryoablation SystemCSS-20040542025-05-05
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
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00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28