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510(k) Data Aggregation

    K Number
    K243886
    Device Name
    ExpressCore Biopsy Device
    Manufacturer
    INRAD, Inc
    Date Cleared
    2025-04-29

    (132 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.
    Device Description
    The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.
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    K Number
    K240429
    Device Name
    Trilogy Tissue Marker
    Manufacturer
    INRAD Inc.
    Date Cleared
    2024-11-07

    (268 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.
    Device Description
    The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.
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    K Number
    K183503
    Device Name
    EasyMark Tissue Marker
    Manufacturer
    INRAD Inc.
    Date Cleared
    2019-10-17

    (304 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
    Device Description
    The EasyMark Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 17 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. This device offers the user the choice of two unique tissue markers (i) 316 LVM Stainless Steel Anchor shaped Marker (ii) Titanium 6AI-4V ELI Ribbon shaped Marker.
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    K Number
    K112945
    Device Name
    ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
    Manufacturer
    INRAD INC.
    Date Cleared
    2011-11-03

    (30 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
    Device Description
    The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.
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    K Number
    K110608
    Device Name
    SEVOFLURANE VAPORIZER ADAPTOR
    Manufacturer
    PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)
    Date Cleared
    2011-07-20

    (139 days)

    Product Code
    CAD
    Regulation Number
    868.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
    Device Description
    The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.
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    K Number
    K093399
    Device Name
    PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
    Manufacturer
    INRAD
    Date Cleared
    2009-11-19

    (17 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
    Device Description
    The PreciseCore™ Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The stylet of the device is stationary, therefore acquiring tissue without an advancement of the needle set beyond the visualized tip.
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    K Number
    K093256
    Device Name
    SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
    Manufacturer
    INRAD
    Date Cleared
    2009-11-17

    (29 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
    Device Description
    The SelectCore™ Variable Throw Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The device offers the user the choice of either single fire or fully automatic modes. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
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    K Number
    K090611
    Device Name
    REVOLUTION FULL CORE BIOPSY
    Manufacturer
    INRAD
    Date Cleared
    2009-06-04

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    INRAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
    Device Description
    The Revolution™ Full Core Blopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the Revolution™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
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    K Number
    K072255
    Device Name
    MINRAD INC. NASAL SCAVENGING CIRCUIT
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2007-10-18

    (66 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.
    Device Description
    The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.
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    K Number
    K071814
    Device Name
    LIGHT SABRE SPINAL ACCESS DEVICE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2007-10-16

    (106 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.
    Device Description
    The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.
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