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510(k) Data Aggregation

    K Number
    K203668
    Device Name
    RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
    Date Cleared
    2021-09-29

    (287 days)

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

    MYCO Medical Supplies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
    Device Description
    RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use. The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards. RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration. Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in sterile and non-sterile packaging. Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging. The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths. Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.
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    K Number
    K173279
    Device Name
    RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
    Date Cleared
    2018-05-14

    (213 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCO Medical Supplies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are intended to enable withdrawal of blood samples from a patient. The RELI® Safety Blood Collection Tube Holder is designed to prevent accidental needle stick injuries.
    Device Description
    The RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder are intended to be used in combination with conventional multiple sample blood collection needles (up to 1 ½" in length) and vacutainers for safe handling and disposal immediately following routine venipuncture procedures. The Safety Blood Collection Tube Holder is designed with a user activated safety shield to cover the needle immediately following venipuncture procedure to help prevent needle stick injuries and safely dispose of the device in compliance with OSHA requirements. The safety shield can be activated by gently pressing the shield toward the needle in one of two ways without the need for user to approach the sharp end: 1) Press shield toward exposed needle on a stable surface or 2) With thumb behind the shield, press shield onto exposed needle. An audible click is heard when the safety shield has been properly activated and the Safety Blood Collection Tube Holder with enclosed needle is safe to discard. The Safety Blood Collection Tube Holder is clear with safety shield available in clear, blue, or orange color options. The Blood Collection Tube Holder is clear. The devices can be used with conventional multi-sample needles up to 1 ½ inches in length.
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    K Number
    K161737
    Device Name
    RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
    Manufacturer
    Date Cleared
    2017-03-02

    (252 days)

    Product Code
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCO MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.
    Device Description
    The REDIDIOX is a (Polydioxanone) monofilament synthetic absorbable suture prepared from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3). Polydioxanone polymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. Based on absorption study it takes 182 days for total absorption. The monofilament material is available undyed and dyed. The dyed material is colored violet, dyed with D&C Violet. REDIDIOX sutures comply with USP requirements, except for diameter.
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    K Number
    K090426
    Device Name
    VAKU-8 BLOOD COLLECTION NEEDLES
    Date Cleared
    2009-06-12

    (113 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCO MEDICAL SUPPLIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VAKU-8™ Blood Collection Needles are designed for routine blood collection by a qualified practitioner
    Device Description
    VAKU-8™ Single use Multi Sample blood collection needles are composed of a stainless steel needle tube that is ground at both ends and affixed to a plastic hub. A rubber sleeve covers the backend needle tube and hub tip. The front end needle is used to withdraw blood once placed in the patient. The needle tube is protected by a plastic needle cover on either end. The "front end needle" is designed to withdraw blood from the patient. The "back end needle" is covered by a rubber sleeve and is designed with a threaded hub that can be attached to a blood collection tube holder. The tube holder facilitates attachment to a evacuated blood collection tube. Each needle is individually packaged sterile utilizing two plastic end covers. A perforated label serves to simplify identification of needle size and also acts as a seal of integrity.
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    K Number
    K042504
    Device Name
    CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
    Date Cleared
    2006-01-19

    (491 days)

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

    MYCO MEDICAL SUPPLIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids intravenously. Cathy IV Cannula may be used for writtence of propoduce intravenously. Cathy IV Califiala may be accurity of the may of procedure.
    Device Description
    Not Found
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    K Number
    K020934
    Device Name
    DR. JAPAN FACIL POINT SPINAL NEEDLE
    Manufacturer
    Date Cleared
    2002-10-25

    (217 days)

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

    MYCO MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For spinal administration of anesthetic agents to provide regional anesthesia.
    Device Description
    Not Found
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    K Number
    K000592
    Device Name
    UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
    Date Cleared
    2001-04-12

    (415 days)

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

    MYCO MEDICAL SUPPLIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K990519
    Device Name
    PHOENIX EPIDURAL & SPINAL NEEDLES
    Date Cleared
    2000-06-02

    (470 days)

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

    MYCO MEDICAL SUPPLIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
    Device Description
    "Phoenix" Epidural and Spinal Needles.
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    K Number
    K982646
    Device Name
    AILEE SUTURES AND AILEE NEEDLES
    Date Cleared
    1999-06-02

    (308 days)

    Regulation Number
    878.4830
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCO MEDICAL SUPPLIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Chromic Gut surgical sutures are indicated for use as absorbable sutures in gegeral soft tissue approximation and/or ligation, including use in ophthalmic procedures, out NOT for use in cardiovascular and neural tissue. Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft Catgut plain surgical sutures are indicated of assessments of the subscribed on the researces, but NOT tissue approximation and neural tissue. Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues. Silk sutures are indicated for use as non-absorbable sutures in general soft tissues Silk sutures are indicated for use as non-acolorodolorouse in cardiovascular, ophthalmic, neural tissue. Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue r oreximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue rylon battleoo and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
    Device Description
    Not Found
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    K Number
    K990388
    Device Name
    TUTOPLUS IV ADMINISTRATION SET
    Date Cleared
    1999-03-29

    (49 days)

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

    MYCO MEDICAL SUPPLIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device to be used to administer IV Solution or medication to patient.
    Device Description
    "TUTOPLUS" Sterile Disposable Intravascular Administration Set
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