FDA.reportPublic FDA data

Spirotome

Primary DI
05407005000113
Brand
Spirotome
Company
Bioncise
Model
SS1415
Catalog number
SS1415
Device description
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissu
Published
2018-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K080095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080095000CORAMATE/SPIROTOME SYSTEMMedinvents2008-04-11KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407005000113PackageGS15In Commercial Distribution
05407005001110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407005000113054070050001135407005000113
05407005001110054070050011105407005001110

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for hsitopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
371402316
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05407005001011SpirotomeSS0820SS08202018-08-31
05407005001035SpirotomeSS0810SS08102018-08-31
05407005001042SpirotomeSS0808SS08082018-08-31
05407005001059SpirotomeSS0806SS08062018-08-31
05407005001073SpirotomeSS1015SS10152018-08-31
05407005001080SpirotomeSS1010SS10102018-08-31
05407005001097SpirotomeSS1008SS10082018-08-31
05407005001103SpirotomeSS1006SS10062018-08-31
05407005001110SpirotomeSS1415SS14152018-08-31
05407005001127SpirotomeSS1410SS14102018-08-31
05407005001134SpirotomeSS1408SS14082018-08-31
05407005001141SpirotomeSS1406SS14062018-08-31
05407005001158SpirotomeSS08MRSS08MR2018-08-31
05407005001165SpirotomeSS10MRSSA10MR2018-08-31
05407005001172Spirotome CervicoreSS10CESS10CE2018-08-31
05407005001189Spirotome CervicoreSS08CESS08CC2018-08-31
05407005001196Spirotome EndoSS08ENSS08EN2018-08-31
05407005001202Spirotome EndoSS10ENSS10EN2018-08-31
05407005001219Spirotome EndoSS14ENSS14EN2018-08-31
05407005001226Spirotome EndoSS14EN1SS14EN12018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636256CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31