FDA.reportPublic FDA data

Curaway

Primary DI
06937278635518
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
BN-MAR-8/2115
Device description
Disposable Biopsy Needle
Published
2026-08-15
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
16937278635515PackageGS110In Commercial Distribution
26937278635512PackageGS19In Commercial Distribution
06937278635518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727863551516937278635515
2693727863551226937278635512
06937278635518069372786355186937278635518

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
06936666568834CurawayBNMA/CB-1-3.5(9G)/1502026-11-05
06937278664563CurawayBN-OCR-13/14082026-11-05
06937278664570CurawayBN-OCR-13/14102026-11-05
06937278664587CurawayBN-OCR-13/14132026-11-05
06937278664594CurawayBN-OCR-13/14162026-11-05
06937278664600CurawayBN-OCR-13/14202026-11-05
06937278664617CurawayBN-OCR-13/14252026-11-05
06937278664624CurawayBN-OCR-13/16082026-11-05
06937278664631CurawayBN-OCR-13/16102026-11-05
06937278664648CurawayBN-OCR-13/16132026-11-05
06937278664655CurawayBN-OCR-13/16162026-11-05
06937278664662CurawayBN-OCR-13/16202026-11-05
06937278664679CurawayBN-OCR-13/16252026-11-05
06937278664686CurawayBN-OCR-13/18082026-11-05
06937278664693CurawayBN-OCR-13/18102026-11-05
06937278664709CurawayBN-OCR-13/18132026-11-05
06937278664716CurawayBN-OCR-13/18162026-11-05
06937278664723CurawayBN-OCR-13/18202026-11-05
06937278664730CurawayBN-OCR-13/18252026-11-05
06937278664747CurawayBN-OCR-13/20082026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936666568834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664563CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664570CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664587CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664594CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664600CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664617CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664624CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664631CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664648CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664655CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664662CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664679CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664686CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664693CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664709CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664716CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664723CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664730CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664747CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664754CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664761CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664778CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664785CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664792CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664808CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664815CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664822CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664839CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664846CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05