FDA.reportPublic FDA data

Cryoprobe

Primary DI
17290015487549
Brand
Cryoprobe
Company
ICECURE MEDICAL LTD
Model
CP-2004059
Device description
90-degree handle
Published
2025-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
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
17290015487549PackageGS15In Commercial Distribution
07290015487542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001548754917290015487549
07290015487542072900154875427290015487542

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held cryosurgical system handpiece tipA sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge10Gauge
Shaft Length140Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 millibar1000 millibar
Handling Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-22 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
514758619
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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