FDA.reportPublic FDA data

Curaway

Primary DI
06937278636133
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
BN-OCR-1/1618
Device description
Automatic Core Biopsy Instrument
Published
2026-05-31
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
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
16937278636130PackageGS15In Commercial Distribution
26937278636137PackageGS110In Commercial Distribution
06937278636133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727863613016937278636130
2693727863613726937278636137
06937278636133069372786361336937278636133

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. 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