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510(k) Data Aggregation

    K Number
    K052365
    Device Name
    CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
    Manufacturer
    ROCKET MEDICAL PLC
    Date Cleared
    2005-10-17

    (49 days)

    Product Code
    HEE
    Regulation Number
    884.5100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies. For use with 2.2ml glass vials, such as those containing local anaesthetic agents.
    Device Description
    CerviNeedle™ Disposable Cartridge Syringe
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    K Number
    K021224
    Device Name
    ENDOCERVICAL BLOCK NEEDLE
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    2002-07-12

    (86 days)

    Product Code
    HEE, FMI
    Regulation Number
    884.5100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.
    Device Description
    The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.
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    K Number
    K983897
    Device Name
    CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
    Manufacturer
    RI MOS. S.R.L.
    Date Cleared
    1999-02-01

    (90 days)

    Product Code
    HEE
    Regulation Number
    884.5100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.
    Device Description
    The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
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    K Number
    K980238
    Device Name
    GYNEX EXTENDED REACH NEEDLE
    Manufacturer
    GYNEX CORP.
    Date Cleared
    1998-08-21

    (210 days)

    Product Code
    HEE, 85H
    Regulation Number
    884.5100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both. 2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.
    Device Description
    The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.
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    K Number
    K982097
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-06-25

    (10 days)

    Product Code
    FMI
    Regulation Number
    880.5570
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.
    Device Description
    Worldwide Medical Technologies Intracervical Block Needle
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    K Number
    K973671
    Device Name
    ENDOCERVICAL BLOCK NEEDLE
    Manufacturer
    A & A MEDICAL, INC.
    Date Cleared
    1997-11-26

    (61 days)

    Product Code
    HEE
    Regulation Number
    884.5100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix Local anesthetics such as electroexcision, electrofulguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cervical blopsies
    Device Description
    The needle is 27g, 3 ½ª long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal lube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intravascular administration set. Over 3 ¼" of its proximal end a 21 gauge metal tube is added to strengthen the shaft
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