FDA.reportPublic FDA data

Curaway

Primary DI
16937278648973
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
Cura RF Electrode Fixed 15-25s40FD
Device description
Cura RF Electrode
Published
2025-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16937278648973PackageGS110In Commercial Distribution
06937278648976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727864897316937278648973
06937278648976069372786489766937278648976

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
412923111
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
false
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 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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