FDA.reportPublic FDA data

HYGEA

Primary DI
06935650602059
Brand
HYGEA
Company
Hygea Medical Technology Co., Ltd.
Model
Ease TSL08
Device description
The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System to measure the temperature of solid tumors excluding the cavity tumors and surrounding tissues.
Published
2025-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
K243042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243042000Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.2025-01-29GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935650602059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935650602059069356506020596935650602059

GMDN Terms#

Term, Definition table
TermDefinition
Cryosurgical system temperature probeA hand-held device intended to be used to monitor tissue temperature during a cryosurgical procedure, typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the cryosurgical system control unit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
549765730
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935650621319HYGEAExact HP-1805080U2025-09-08
06935650621333HYGEAExact HP-1605100U2025-09-08
06935650621357HYGEAExact HP-1507200U2025-09-08
06935650621371HYGEAExact HP-1512200U2025-09-08
06935650622613HYGEAExact HC-1814100U2025-09-08
06935650622620HYGEAExact HC-1814150U2025-09-08
06935650622637HYGEAExact HC-1814200U2025-09-08
06935650622651HYGEAExact HC-1614150U2025-09-08
06935650622668HYGEAExact HC-1614200U2025-09-08
06935650622682HYGEAExact HC-1514150U2025-09-08
06935650622699HYGEAExact HC-1514200U2025-09-08
06935650622729HYGEAExact HC-1414250U2025-09-08
06935650623344HYGEAExact HS-1425150U2025-09-08
06935650623351HYGEAExact HS-1425200U2025-09-08
06935650624327HYGEAExact HT-1414200U2025-09-08
06935650602042HYGEAEase TSS082025-09-08
06935650602066HYGEAEase TMS152025-09-08
06935650602073HYGEAEase TML152025-09-08
06935650603049HYGEAElite RAL302025-09-08
06935650603056HYGEAElite RAS302025-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
10888853004836Freeze Away Pinpoint Skin Tag RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-10-01
10888853004867Freeze Away Sub Zero Wart RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-09-10
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08