FDA.reportPublic FDA data

Aliya Electrode

Primary DI
10850031859026
Brand
Aliya Electrode
Company
Galvanize Therapeutics, Inc.
Model
GTI-00024
Device description
Aliya Electrode, 5 pack
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OABLow Energy Direct Current Thermal Ablation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OABLow Energy Direct Current Thermal Ablation SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212871000Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeGalvanize Therapeutics, Inc.2022-06-17OAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850031859026PrimaryGS10
00850031859029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003185902610850031859026
00850031859029008500318590298500318590290850031859029

GMDN Terms#

Term, Definition table
TermDefinition
Irreversible electroporation system percutaneous probe connection electrodeA slender electrical conductor with a connection cable intended to be inserted within the lumen of an irreversible electroporation system percutaneous probe to deliver short electrical pulses, in a monopolar configuration, from a system generator to the probe to produce irreversible cell membrane electroporation. The thin distal electrode is intended to be inserted within the probe lumen for during ablation of soft tissue (excludes cardiac tissue); it does not have direct contact with tissues (i.e., not a probe). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070000990
Device count
5
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
00850031859098Aliya EX GeneratorGTI-000712026-05-14
00850031859128Aliya PEF Ablation PackGTI-000502026-05-14
00850031859135INUMI Flex Needle PackGTI-000782026-05-14
00850031859173INUMI Flex NeedleGTI-000542026-05-14
00850031859111Aliya NeedleGTI-000232026-05-08
00850031859005Aliya NeedleGTI-000232024-02-21
00850031859029Aliya ElectrodeGTI-000242024-02-21
00850031859074INUMI Flex Needle GTI-000542025-02-28
00850031859036Galvanize CartGTI-000762026-01-22
00850031859104Aliya Generator-RecertifiedGTI-00017R2025-02-28
00850031859043Aliya GeneratorGTI-000172023-08-18
10850031859002Aliya NeedleGTI-000232024-02-21
00850031859050Aliya GeneratorGTI-000172023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936666557958CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557965CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557972CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557989CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557996CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558009CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558016CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558023CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558030CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558047CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558054CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558061CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558078CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558085CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558092CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558108CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558115CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558122CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558139CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558146CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652116CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652123CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652130CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652147CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
06972304750834DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750770DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750787DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750794DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750800DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750817DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22