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510(k) Data Aggregation
K Number
K233294Device Name
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
Manufacturer
Date Cleared
2024-06-18
(263 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
ITP Innovative Tomography Products GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
Device Description
The Semi-automatic Biopsy-Needle - BIM and Automatic Biopsy Needle - BAM are sterile, spring loaded, disposable percutaneous soft tissue biopsy systems. It consists of the following major components: handle, spring, cannula, stylet, trigger and spring guide. It is used to obtain multiple core biopsy samples from soft tissue such as breast, kidney, liver and prostate. The needle has to be inserted by a qualified physician under MR image guidance.
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K Number
K222462Device Name
Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)
Manufacturer
Date Cleared
2023-01-20
(158 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
ITP Innovative Tomography Products GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
Device Description
The semiautomatic Biopsy needle– BM is a sterile, spring loaded, disule biopsy system. It consists of the following maior components: handle stylet. tincer and coring nuide.
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