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510(k) Data Aggregation
K Number
K193268Device Name
APrioCore Plus
Manufacturer
AprioMed AB
Date Cleared
2020-02-27
(93 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
AprioMed AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AprioCore plus is intended for use in obtaining core biopsy specimens from soft tissue such as breast, kidney, liver, lung, thyroid, lymph nodes and various soft tissue masses performed under image guidance techniques for soft tissue biopsy.
Device Description
AprioCore plus is a manually operated, sterile, single use, semi-automatic, spring-loaded biopsy needle. AprioCore plus is provided in a variety of sizes (gauge and length) and is compatible with AprioMed devices Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle.
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K Number
K181756Device Name
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Manufacturer
AprioMed AB
Date Cleared
2018-12-18
(169 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
AprioMed AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
Device Description
Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use.
Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.
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K Number
K150625Device Name
Morrison Steerable Needle
Manufacturer
APRIOMED AB
Date Cleared
2015-06-09
(90 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
APRIOMED AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.
Device Description
The sterile, single use, Morrison Steerable Needle consists of the housing, a rotating lever which controls the deflection of the needle tip, the slide, the collar which transfers tensile force from the slide to the core wire; the tendon wire (core wire) which transfers tensile force from the collar to distal tip of the tubing; the stainless steel tubing which ends in a Menghini like needle tip on the distal end and a luer lock fitting on the proximal end.
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