FDA.reportPublic FDA data

Dophi

Primary DI
06972304750834
Brand
Dophi
Company
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Model
NPG3000
Device description
Electroporation Power Generator
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K240376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240376000Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2024-10-04OAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972304750834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972304750834069723047508346972304750834

GMDN Terms#

Term, Definition table
TermDefinition
Irreversible electroporation system generatorA mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. It includes controls (e.g., foot-switch) and user interface; additional system components necessary for the procedure [e.g., electrocardiogram (ECG) trigger monitor electrode probe/catheter] are not included. It is intended for the nonthermal surgical ablation of soft-tissues and may be intended for one or more clinical application(s).

Regulatory Flags#

DUNS number
550274579
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
06972304750407DeepEyeEVS1002026-05-22
06972304750414DeepEyeEVS2002026-05-22
06972304751404InflaCureGVS1002026-05-22
16972304750381DeepEyeLPS210002026-05-22
16972304750398DeepEyeLPS210302026-05-22
16972304750428DeepEyeLPS310002026-05-22
16972304750435DeepEyeLPS310302026-05-22
16972304750770DophiNSP132026-05-22
16972304750787DophiNSP182026-05-22
16972304750794DophiNSP252026-05-22
16972304750800DophiNTP132026-05-22
16972304750817DophiNTP182026-05-22
16972304750824DophiNTP252026-05-22
16972304750848DophiNFS062026-05-22
16972304751555InflaCureGI-S0012026-05-22
16972304750015DophiSS-TP18G-202022-01-19
06972304750209DophiR150E2022-03-07
06972304751411DophiSJ-A012022-03-07
16972304750022DophiSS-RFAS1-15102022-03-07
16972304750039DophiSS-RFAS1-15202022-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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