FDA.reportPublic FDA data

Aliya PEF Ablation Pack

Primary DI
00850031859128
Brand
Aliya PEF Ablation Pack
Company
Galvanize Therapeutics, Inc.
Model
GTI-00050
Device description
Aliya PEF Ablation Pack, 5 Pack and 1 Pack
Published
2026-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00850031859142PackageGS15In Commercial Distribution
00850031859159PackageGS11In Commercial Distribution
00850031859128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031859142008500318591428500318591420850031859142
00850031859159008500318591598500318591590850031859159
00850031859128008500318591288500318591280850031859128

GMDN Terms#

Term, Definition table
TermDefinition
Irreversible electroporation system percutaneous probeA hollow, long, tubular electrical conductor with a sharply-pointed distal end intended for percutaneous introduction within soft tissue to deliver short electrical pulses, in a monopolar configuration, to produce irreversible cell membrane electroporation for ablation of soft tissue (excludes cardiac tissue). It is intended to be connected to a connection electrode with a connection cable for use in conjunction with an appropriate generator. It may include a stylet intended to facilitate introduction; the connection electrode and connection cable are not included. 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
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
10850031859026Aliya ElectrodeGTI-000242024-02-21
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