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510(k) Data Aggregation

    K Number
    K163292
    Device Name
    Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
    Date Cleared
    2017-09-08

    (290 days)

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

    SPECTRA MEDICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The cannulas/needles for anesthesia and analgesia enhanced for ultrasound visibility - Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter.
    Device Description
    The Spectra Sonic Block Needles consist of a stainless steel needle and a clear standard female Luer locking hub. The needles are available in a range of needle tip configuration, gauges and lengths to match the end-user need. These needles have an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Sonic Block Needles will be marketed as sterile, non-pyrogenic, and single use devices. The needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles / cannulas may be used during all anesthesia and analgesia procedures according to the physician's indication. Needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are standard needles /cannulas equipped with dimpled echogenic tip in order to significantly enhance ultrasound visibility. This surface technology allows for a variety of sizes. The inner diameter is not effect by the echogenic treatment. This feature completely encircles the tip of the needles / cannulas so all sides appear bright under ultrasound. In order to enhance ultrasound visibility, the needles / cannulas are equipped with a special dimpled pattern named Sonic Block dimples to the needles / cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.
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    K Number
    K151069
    Device Name
    SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
    Date Cleared
    2016-02-05

    (290 days)

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

    SPECTRA MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or an extension set.
    Device Description
    The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle consists of a stainless steel needle and a clear or colored (translucent) standard female Luer lock square or round Hub locking connector for rapid (flashback) visualization. The stainless steel needles are available with and without an echogenic feature (i.e. mechanical dimpling treatment to the needle point surface), and with or without lubrication. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need (16 to 30 gauges).
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    K Number
    K142791
    Device Name
    Spectra Soft Tissue Biopsy Needles
    Date Cleared
    2015-01-21

    (117 days)

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

    SPECTRA MEDICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.
    Device Description
    The Spectra Soft Tissue and Aspiration Biopsy Needles consist of a stainless steel needle and a translucent standard female Luer locking hub. A stylet rod assembly mates with the needle hub assembly. A depth stop is integral with each needle type to facilitate depth placement. The needle assembly is covered by a translucent removable needle guard. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. Needles are available with an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Soft Tissue Biopsy Needles will be marketed as sterile, non-pyrogenic, and single use devices.
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    K Number
    K103740
    Device Name
    SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
    Date Cleared
    2011-07-29

    (219 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRA MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
    Device Description
    Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule.
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    K Number
    K082689
    Device Name
    STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
    Date Cleared
    2009-03-20

    (186 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRA MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
    Device Description
    Spectra Medical's, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule
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    K Number
    K082580
    Device Name
    SPECTRA GUIDEWIRE INTRODUCER NEEDLE
    Date Cleared
    2008-12-08

    (94 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRA MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures. The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.
    Device Description
    The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewwire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.
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    K Number
    K082674
    Device Name
    SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
    Date Cleared
    2008-11-28

    (74 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRA MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
    Device Description
    Spectra, GLASS LOR SYRINGE
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    K Number
    K081524
    Device Name
    SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
    Date Cleared
    2008-07-29

    (57 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRA MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SPECTRA-LOR, Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
    Device Description
    The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syringe; it has a barrel, a plunger and a bung. The barrel has graduations which correspond to a capacity of 10 ml and is available in a Luer Lock or Luer Slip tip.
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