FDA.reportPublic FDA data

PROSENSE™ SYSTEM 100-127 VAC

Primary DI
07290015487290
Brand
PROSENSE™ SYSTEM 100-127 VAC
Company
ICECURE MEDICAL LTD
Model
FAS3000000-2
Catalog number
FAS3000000-2
Device description
PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle
Published
2021-08-11
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
K183213000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015487290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015487290072900154872907290015487290

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 used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

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
+18889025716icecuresupport@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
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
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
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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
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