FDA.reportPublic FDA data

Curaway

Primary DI
16936666559372
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
CFB 2.3-2-60
Device description
Endovenous Radiofrequency Catheter
Published
2025-09-01
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
K232505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232505000Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterZhejiang Curaway Medical Technology Co., Ltd.2024-05-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936666559372PackageGS110In Commercial Distribution
06936666559375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693666655937216936666559372
06936666559375069366665593756936666559375

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular electrocautery catheter, single-useA flexible catheter with a distal heating element/electrode intended to be connected to an electrical generator and introduced into the peripheral vasculature to ablate venous tissues, through direct application of heat, as a treatment for venous reflux disease (varicose veins); it is not intended to introduce electrical current into the body. It is a luminal device with a proximal handle with controls (e.g., on/off switch) that is introduced via an introducer assembly (which may be included), and is typically maneuvered under external image guidance [e.g., ultrasound (US)]. 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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