FDA.reportPublic FDA data

Aliya Needle

Primary DI
00850031859005
Brand
Aliya Needle
Company
Galvanize Therapeutics, Inc.
Model
GTI-00023
Device description
Aliya Needle, 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
10850031859002PackageGS15In Commercial Distribution
00850031859005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003185900210850031859002
00850031859005008500318590058500318590050850031859005

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
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
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
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
00850031859029Aliya ElectrodeGalvanize 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