FDA.reportPublic FDA data

Curaway

Primary DI
06937278649904
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
Cura RF Electrode Adjustable 18-15s05-25AT
Device description
Cura RF Electrode
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240758000Radiofrequency Generator System, Cura RF ElectrodeZhejiang Curaway Medical Technology Co., Ltd.2024-12-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16937278649901PackageGS16In Commercial Distribution
06937278649904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727864990116937278649901
06937278649904069372786499046937278649904

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolarA semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.

Regulatory Flags#

DUNS number
412923111
Device count
1
Lot or batch
true
Expiration 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

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Primary DI, Brand, Company table
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