FDA.reportPublic FDA data

C2 CryoBalloon Ablation System

Primary DI
00854924006255
Brand
C2 CryoBalloon Ablation System
Company
PENTAX OF AMERICA, INC.
Model
FG-1025
Device description
Gen 2 360 Degree Pear Catheter
Published
2025-04-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854924006255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854924006255008549240062558549240062550854924006255

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheter, non-medicatedA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08
04961333242320N/A92092/62018-03-08

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