FDA.reportPublic FDA data

Curaway

Primary DI
06937278664679
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
BN-OCR-13/1625
Device description
Automatic Core Biopsy Instrument
Published
2026-11-05
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
K241793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241793000Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.2025-01-24KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16937278664676PackageGS15In Commercial Distribution
26937278664673PackageGS18In Commercial Distribution
06937278664679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727866467616937278664676
2693727866467326937278664673
06937278664679069372786646796937278664679

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
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
06937278664754CurawayBN-OCR-13/20102026-11-05

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
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
06937278664853CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05