FDA.reportPublic FDA data

Aliya Electrode

Primary DI
00850031859029
Brand
Aliya Electrode
Company
Galvanize Therapeutics, Inc.
Model
GTI-00024
Device description
Aliya Electrode, 5 pack
Published
2024-02-21
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
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
10850031859026PackageGS15In Commercial Distribution
00850031859029PrimaryGS10

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

Regulatory Flags#

DUNS number
070000990
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
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
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
10850031859026Aliya ElectrodeGTI-000242024-02-21
00850031859050Aliya GeneratorGTI-000172023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16972304750824DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750848DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
00850031859098Aliya EX GeneratorGalvanize Therapeutics, Inc.OAB2026-05-14
00850031859128Aliya PEF Ablation PackGalvanize Therapeutics, Inc.OAB2026-05-14
00850031859135INUMI Flex Needle PackGalvanize Therapeutics, Inc.OAB2026-05-14
00850031859173INUMI Flex NeedleGalvanize Therapeutics, Inc.OAB2026-05-14
00850031859111Aliya NeedleGalvanize Therapeutics, Inc.OAB2026-05-08
15051684030069NanoKnifeAngiodynamics, Inc.OAB2026-05-04
15051684013727NanoKnifeAngiodynamics, Inc.OAB2026-04-30
15051684017930NanoKnifeAngiodynamics, Inc.OAB2026-04-30
15051684017947NanoKnifeAngiodynamics, Inc.OAB2026-04-30
15051684017954NanoKnifeAngiodynamics, Inc.OAB2026-04-30
15051684029643NanoKnifeAngiodynamics, Inc.OAB2026-04-30
06936666557944CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2025-08-11
00850031859074INUMI Flex Needle Galvanize Therapeutics, Inc.OAB2025-02-28
00850031859104Aliya Generator-RecertifiedGalvanize Therapeutics, Inc.OAB2025-02-28
B413XL1000CP0US Medical InnovationsUS MEDICAL INNOVATIONS, LLCOAB2024-06-24
00850031859005Aliya NeedleGalvanize Therapeutics, Inc.OAB2024-02-21
10850031859002Aliya NeedleGalvanize Therapeutics, Inc.OAB2024-02-21
10850031859026Aliya ElectrodeGalvanize Therapeutics, Inc.OAB2024-02-21
00850031859043Aliya GeneratorGalvanize Therapeutics, Inc.OAB2023-08-18
00850031859050Aliya GeneratorGalvanize Therapeutics, Inc.OAB2023-08-18
H787204001110NanoKnifeANGIODYNAMICS, INC.OAB2022-10-07
H78720300301US0NanoKnifeANGIODYNAMICS, INC.OAB2019-07-01