FDA.reportPublic FDA data

Semi-automatic Biopsy Needle - BIM16/20i

Primary DI
04262410687073
Brand
Semi-automatic Biopsy Needle - BIM16/20i
Company
ITP Innovative Tomography Products GmbH
Model
BIM16/20i
Device description
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K233294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233294000Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH2024-06-18KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262410687080PackageGS110In Commercial Distribution
04262410687073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262410687080042624106870804262410687080
04262410687073042624106870734262410687073

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core 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, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Millimeter
Needle Gauge16Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius23 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4923454621940sales@innotom.com

Regulatory Flags#

DUNS number
341493551
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262410680821Semi-automatic Biopsy Needle - BIM16/10iBIM16/10i2025-09-12
04262410680852Semi-automatic Biopsy Needle - BIM18/10iBIM18/10i2025-09-12
04262410687110Semi-automatic Biopsy Needle - BIM16/15iBIM16/15i2025-09-12
04262410680838Semi-automatic Biopsy Needle - BIM16/10iBIM16/10i2025-09-12
04262410680845Semi-automatic Biopsy Needle - BIM18/10iBIM18/10i2025-09-12
04262410687080Semi-automatic Biopsy Needle - BIM16/20iBIM16/20i2025-09-12
04262410687127Semi-automatic Biopsy Needle - BIM16/15iBIM16/15i2025-09-12
04262410687059Semi-automatic Biopsy Needle - BIM18/15iBIM18/15i2025-07-09
04262410687066Semi-automatic Biopsy Needle - BIM18/15iBIM18/15i2025-07-09
04262410687011Semi-automatic Biopsy Needle - BIM18/20iBIM18/20i2025-04-29
04262410687028Semi-automatic Biopsy Needle - BIM18/20iBIM18/20i2025-04-29
04262410686083Automatic Biopsy Needle - BAM 16/17BAM16/172025-04-23
04262410686106Automatic Biopsy Needle - BAM 16/15BAM16/152025-04-23
04262410686090Automatic Biopsy Needle - BAM 16/17BAM16/172025-04-23
04262410686113Automatic Biopsy Needle - BAM 16/15BAM16/152025-04-23
04262410680166Coaxial Interventional NeedleKIM18/102025-04-08
04262410680173Coaxial Interventional NeedleKIM18/102025-04-08
04262410680340Coaxial Interventional NeedleKIM15/09T2025-03-13
04262410680357Coaxial Interventional NeedleKIM15/09T2025-03-13
04262410680029Coaxial Interventional NeedleKIM22/052025-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103776Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-06-09
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