FDA.reportPublic FDA data

Curaway

Primary DI
06937278628381
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
BN-MAR-1/1613
Device description
Disposable Biopsy Needle
Published
2026-07-31
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
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244018000Disposable Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.2025-07-22KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16937278628388PackageGS110In Commercial Distribution
26937278628385PackageGS115In Commercial Distribution
06937278628381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727862838816937278628388
2693727862838526937278628385
06937278628381069372786283816937278628381

GMDN Terms#

Term, Definition table
TermDefinition
Cell-block cytology aspiration needleA sterile, sharp bevel-edged, hollow tubular metal instrument, combined with a Luer connector containing an absorbent foam pad, intended to be used for the collection of a biopsy specimen by fine needle aspiration (FNA) and to enable cells in a fluid specimen to be incorporated into a cell block; it is not dedicated to a particular part of the anatomy. Cells from the aspirate are captured in the foam pad enabling processing and analysis of the specimen using techniques typically applied to solid tissue specimens (e.g., paraffin processing, histological sectioning, immunohistochemistry, in situ hybridization). This is a single-use device.

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
06936666568636CurawayBNMAB-1-1.2(18G)/252026-07-31
06936666568643CurawayBNMAB-1-1.2(18G)/402026-07-31
06936666568650CurawayBNMAB-1-1.2(18G)/552026-07-31
06936666568667CurawayBNMAB-1-1.6(16G)/252026-07-31
06936666568674CurawayBNMAB-1-1.6(16G)/402026-07-31
06936666568681CurawayBNMAB-1-1.6(16G)/552026-07-31
06936666568698CurawayBNMAB-1-1.8(15G)/252026-07-31
06936666568704CurawayBNMAB-1-1.8(15G)/402026-07-31
06936666568711CurawayBNMAB-1-1.8(15G)/552026-07-31
06936666568728CurawayBNMAB-1-2.1(14G)/252026-07-31
06936666568735CurawayBNMAB-1-2.1(14G)/402026-07-31
06936666568742CurawayBNMAB-1-2.1(14G)/552026-07-31
06936666568759CurawayBNMA/CB-1-2.4(13G)/702026-07-31
06936666568766CurawayBNMA/CB-1-2.4(13G)/1002026-07-31
06936666568773CurawayBNMA/CB-1-2.4(13G)/1502026-07-31
06936666568780CurawayBNMA/CB-1-3.0(11G)/702026-07-31
06936666568797CurawayBNMA/CB-1-3.0(11G)/1002026-07-31
06936666568803CurawayBNMA/CB-1-3.0(11G)/1502026-07-31
06936666568810CurawayBNMA/CB-1-3.5(9G)/702026-07-31
06936666568827CurawayBNMA/CB-1-3.5(9G)/1002026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936666568636CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568711CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568728CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568735CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568742CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568759CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568766CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568773CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568780CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568797CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568803CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568810CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628299CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628305CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628312CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628329CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628336CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628343CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628350CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628367CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628374CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31