FDA.reportPublic FDA data

Accurett

Primary DI
B386SACT100
Brand
Accurett
Company
H & O Equipments SA
Model
Accurett
Catalog number
S-ACT-10
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K161615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161615000AccurettH&O Equipments, Nv/Sa2016-08-23GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B386SACT100PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-2671550info@accurett.com

Regulatory Flags#

DUNS number
370212933
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15407008487000FrostAway™FrostAway PenFROSTAWAYPEN2025-05-19
15407008487017FrostAway™FrostAway Pen cartridgesFROSTAWAYPEN-CA2025-05-18
05407008487003FrostAway™FrostAway Pen cartridgesFROSTAWAYPEN-CA2025-05-18
15407008481527CryoProbe™CryoProbe XP+S-HO-CEPRPLUS-002025-03-10
15407008483514Freezpen®Freezpen 35gCL-FPU-362023-03-12
15407008481022CryoProbe™CryoProbe MS-HO-CMPR-012023-03-12
15407008481114CryoProbe™CryoProbe X+S-HO-CXPRP-022023-03-12
15407008481213CryoProbe™CryoProbe B+S-HO-CBPLUSPR-062023-03-12
15407008481312CryoProbe™CryoProbe O+S-HO-COPR-022023-03-12
15407008481510CryoProbe™CryoProbe XPS-HO-CEPR-012023-03-12
15407008483118Freezpen®Freezpen 8gCL-FPU-032023-03-12
15407008483316Freezpen®Freezpen 16gCL-FPU-192023-03-12
15407008481602CryoProbe™CryoProbe XPSS-HO-CESPR-002023-03-08
15407008482500CryoProbe™23g cartridges for CryoProbeS-HO-NO23-XX-S06-PR2021-04-14
B386CLN2O8GBOX1Freezpen8g N2O cartridges for FreezpenCL-N2O-8G-BOX2016-09-24
B386SHONO23XXS06PR1CryoProbe23g N2O cartridgesS-HO-NO23-XX-S06-PR2016-09-24
B386SHONOCX12S24PR1CryoProbe8g N2O cartridgesS-HO-NOCX-12-S24-PR2016-09-24
B386SHONOCXPR12S061CryoProbe16g N2O cartridgesS-HO-NOCX-PR-12-S062016-09-24
B386SNOR101CryoProbeN2O 8g cartridges and filtersS-NOR102016-09-24
B386CLFPU020Freezpen® Freezpen 8GCL-FPU-022019-05-15

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