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510(k) Data Aggregation

    K Number
    K141285
    Device Name
    BUSSE EXTENSION SET
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES
    Date Cleared
    2015-02-19

    (279 days)

    Product Code
    FPA, FPK
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.
    Device Description
    Busse Extension Set consists of PVC tubing with or without connectors. The tubing accessories include; 3-way connectors, clamps, male and female luer lock, luer slip fitting, and valves. The Extension Set will be provided as sterile, single use only and will be packaged individually and in medical convenience kits. The Extension Sets will be available in a variety of lengths, starting from 6" to 36".
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    K Number
    K120002
    Device Name
    I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2012-06-26

    (175 days)

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

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for aspiration of bone marrow.
    Device Description
    The I-Style Bone Marrow Aspiration Needle with T-Handle consists of a 15G and 18G needle with a triple sharpened atraumatic tip stylet of corresponding size all made of AISI 304 Stainless steel. The needle has an ergonomic grip at whose base a Luer-Lock cone in fitted. The innovative element of the needle is a removable spacer, which indicates the depths the tip can reach. Using a depth stopper, easy adjustment of the needle length, making it easier to reach the tissue to be examined.
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    K Number
    K110883
    Device Name
    J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES
    Date Cleared
    2011-06-08

    (70 days)

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

    BUSSE HOSPITAL DISPOSABLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Biopsy Instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Acquisition Cannula intended to contain the specimen during withdrawal from the needle's cannula.
    Device Description
    The J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula consists of a J-style Bone Marrow Biopsy / Aspiration Needle with cap, providing the physician with greater torque than similar instruments, an ABS Ergonomic grip handle, which increases accuracy and speeds biopsy operation. It comes in 3 sizes; 8G x 4", 11G X 4", and 13G x 4". A Stylet, consisting of a locking mechanism to secure position in Biopsy needle, as well as a stainless steel cannula with a trocar tip for easier penetration into bone tissue. The Snare-it Marrow Acquisition Cannula is designed to allow the tissue to remain intact during removal. This allows for accurate analysis. It also allows additional sample collection without having to re-insert needle into the patient. A stainless steel, sample extractor, allows for convenient sample removal from the cannula. And finally, an extractor Cap.
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    K Number
    K093920
    Device Name
    BUSSE EPIDURAL CATHETER KIT
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES
    Date Cleared
    2010-08-06

    (227 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The epidural catheter is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
    Device Description
    The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.
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    K Number
    K093909
    Device Name
    BUSSE SURGICAL DRAPES IV
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2010-05-06

    (135 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Busse Surgical Drape IV is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide.
    Device Description
    Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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    K Number
    K092212
    Device Name
    BUSSE SURGICAL DRAPES III
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2009-10-09

    (79 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.
    Device Description
    The Laminated Non-Woven Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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    K Number
    K082297
    Device Name
    BUSSE SURGICAL DRAPE
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2008-12-09

    (119 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.
    Device Description
    Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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    K Number
    K073222
    Device Name
    MODIFICATION TO:SPECIALTY NEEDLES
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2008-04-09

    (146 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    specialty needles - Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
    Device Description
    Anesthesia conduction needles consist of different styles. All the needles consist of a plastic or K-Resin hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings, which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)
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    K Number
    K070465
    Device Name
    BUSSE EPIDURAL CATHETER
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2007-07-19

    (153 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
    Device Description
    The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.
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    K Number
    K063018
    Device Name
    GLASS LOSS OF RESISTANCE SYRINGE
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Cleared
    2007-01-22

    (112 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSPITAL DISPOSABLES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glass Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique; it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
    Device Description
    The Glass Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.
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