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510(k) Data Aggregation
K Number
K192099Device Name
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
Manufacturer
Date Cleared
2020-04-02
(241 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Medax Srl Unipersonale
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum.
MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest.
MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy.
MED-B Bone Marrow Biopsy System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy.
MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure.
Device Description
Medax Bone Marrow Biopsy and Aspiration System portfolio is composed by single use devices intended to obtain biopsy samples from bone for histological examinations. Devices are available in different gauge dimensions (identified by different colors) and needle length.
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K Number
K192101Device Name
Medone Ultra, Medextra
Manufacturer
Date Cleared
2020-04-02
(241 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Medax Srl Unipersonale
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy.
MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy.
Device Description
Medax Soft Tissue Biopsy System portfolio is composed by single use devices intended to obtain biopsy samples from soft tissue for histological examinations.
MEDONE ULTRA Devices are available in different gauge dimensions (identified by different colors) and needle length.
Disposable programmable automatic spring-loaded guillotine style biopsy system for histological biopsy on soft tissue.
Disposable semi-automatic spring-loaded guillotine style biopsy system with adjustable penetration depth and rectangular shaped cannula for histological biopsy on lymph nodes and other superficial non-vascular lumps.
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K Number
K181803Device Name
Medax Biopsy Systems III
Manufacturer
Date Cleared
2018-10-18
(105 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Medax Srl Unipersonale
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy
NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy
PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest
HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy.
FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.
Device Description
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K Number
K142125Device Name
New Medax Biopsy Systems
Manufacturer
Date Cleared
2015-12-22
(505 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
MEDAX SRL UNIPERSONALE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BIOFEATHER: biopsy system must be used for histological biopsy on soft tissue.
AVANGARDE: biopsy system must to be used for histological biopsy on soft tissues.
COX: the Co-Axial introducer needle mod. COX must be used when multiple biopsies of soft tissue are required.
Device Description
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