FDA.reportPublic FDA data

Curaway

Primary DI
06936666557944
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
CNP-III
Device description
Irreversible Electroporation Ablation Generator
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K222001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222001000Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.2023-06-08OAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936666557944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936666557944069366665579446936666557944

GMDN Terms#

Term, Definition table
TermDefinition
Irreversible electroporation systemA mobile assembly of devices designed to apply a series of microsecond electrical pulses to tissue to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. The system typically consists of both a mains electricity (AC-powered) computerized current generator with user interface and controls (e.g., foot-switch), and additional necessary components such as electrocardiogram (ECG) trigger monitor and sterile needle-like electrode probes. It is intended for the nonthermal surgical ablation of soft-tissues (e.g., tumours, endothelium).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
412923111
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937278645203CurawayCura RF Electrode Fixed 17-15s10FO2026-04-30
06937278645210CurawayCura RF Electrode Fixed 17-15s15FO2026-04-30
06937278645227CurawayCura RF Electrode Fixed 17-15s20FO2026-04-30
06937278645234CurawayCura RF Electrode Fixed 17-15s25FO2026-04-30
06937278645241CurawayCura RF Electrode Fixed 17-15s30FO2026-04-30
06937278645258CurawayCura RF Electrode Fixed 17-15s40FO2026-04-30
06937278645265CurawayCura RF Electrode Fixed 17-20s10FO2026-04-30
06937278645272CurawayCura RF Electrode Fixed 17-20s15FO2026-04-30
06937278645289CurawayCura RF Electrode Fixed 17-20s20FO2026-04-30
06937278645296CurawayCura RF Electrode Fixed 17-20s25FO2026-04-30
06937278645302CurawayCura RF Electrode Fixed 17-20s30FO2026-04-30
06937278645319CurawayCura RF Electrode Fixed 17-20s40FO2026-04-30
06937278645326CurawayCura RF Electrode Fixed 18-07s05FO2026-04-30
06937278645333CurawayCura RF Electrode Fixed 18-07s07FO2026-04-30
06937278645340CurawayCura RF Electrode Fixed 18-07s10FO2026-04-30
06937278645357CurawayCura RF Electrode Fixed 18-07s15FO2026-04-30
06937278645364CurawayCura RF Electrode Fixed 18-10s05FO2026-04-30
06937278645371CurawayCura RF Electrode Fixed 18-10s07FO2026-04-30
06937278645388CurawayCura RF Electrode Fixed 18-10s10FO2026-04-30
06937278645395CurawayCura RF Electrode Fixed 18-10s15FO2026-04-30

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
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