FDA.report

Dophi

Primary DI
16972304750787
Brand
Dophi
Company
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Model
NSP18
Device description
Electroporation Standard Probe
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OABLow Energy Direct Current Thermal Ablation System

Product Code Classifications

CodeDeviceSpecialtyClass
OABLow Energy Direct Current Thermal Ablation SystemGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K240376000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16972304750787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1697230475078716972304750787

GMDN Terms

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
550274579
Device count
1
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 DIBrandModelCatalogPublished
06972304750407DeepEyeEVS1002026-05-22
06972304750414DeepEyeEVS2002026-05-22
06972304750834DophiNPG30002026-05-22
06972304751404InflaCureGVS1002026-05-22
16972304750381DeepEyeLPS210002026-05-22
16972304750398DeepEyeLPS210302026-05-22
16972304750428DeepEyeLPS310002026-05-22
16972304750435DeepEyeLPS310302026-05-22
16972304750770DophiNSP132026-05-22
16972304750794DophiNSP252026-05-22
16972304750800DophiNTP132026-05-22
16972304750817DophiNTP182026-05-22
16972304750824DophiNTP252026-05-22
16972304750848DophiNFS062026-05-22
16972304751555InflaCureGI-S0012026-05-22
06972304750667VaricureSC300ES2022-10-27
06972304750681VaricureSC200ES2022-10-27
06972304750698VaricureSC100ES2022-10-27
06972304750704VaricureES1002022-10-27
06972304750711VaricureES2002022-10-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06972304750834DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750770DophiSurgnova 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
06936666557944CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2025-08-11
00850031859104Aliya Generator-RecertifiedGalvanize Therapeutics, Inc.OAB2025-02-28
B413XL1000CP0US Medical InnovationsUS MEDICAL INNOVATIONS, LLCOAB2024-06-24
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
15051684029643NanoKnifeANGIODYNAMICS, INC.OAB2022-10-07
H78720300301US0NanoKnifeANGIODYNAMICS, INC.OAB2019-07-01
H787204001090NanoKnifeANGIODYNAMICS, INC.OAB2019-07-01
H787204001100NanoKnifeANGIODYNAMICS, INC.OAB2019-07-01
H787204001015NanoKnifeANGIODYNAMICS, INC.OAB2016-09-22
H787204001025NanoKnifeANGIODYNAMICS, INC.OAB2016-09-22
H787204001035NanoKnifeANGIODYNAMICS, INC.OAB2016-09-22
H787204001045NanoKnifeANGIODYNAMICS, INC.OAB2016-09-22
H787204001055NanoKnifeANGIODYNAMICS, INC.OAB2016-09-22
H787204001065NanoKnifeANGIODYNAMICS, INC.OAB2016-09-22
H787203001010NanoKnifeANGIODYNAMICS, INC.OAB2016-09-21
H78720300101US0NanoKnifeANGIODYNAMICS, INC.OAB2016-09-21
H787204001030NanoKnifeANGIODYNAMICS, INC.OAB2016-09-21
H787204001040NanoKnifeANGIODYNAMICS, INC.OAB2016-09-21
H787204001050NanoKnifeANGIODYNAMICS, INC.OAB2016-09-21
H787204001060NanoKnifeANGIODYNAMICS, INC.OAB2016-09-21