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510(k) Data Aggregation

    K Number
    K102117
    Device Name
    TISSU TRANS FILTRON SYRINGE FILL
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    2010-08-06

    (9 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tissu Trans Filtron Syringe Fill is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus. Tissu Trans Filtron Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue. Tissue Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: - Plastic and Reconstructive Surgery - Neurosurgery - Gastrointestinal and Affiliated Organ Surgery - Urological Surgery - General Surgery - Orthopedic Surgery - Gynecological Surgery - Thoracic Surgery - Laparoscopic Surgery
    Device Description
    Shippert Medical's Tissu Trans Filtron Syringe Fill is an optional accessory to Shippert Medical's Tissu Trans Filtron, k092482. Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration.. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.
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    K Number
    K092482
    Device Name
    TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    2009-12-04

    (113 days)

    Product Code
    MUU, KYZ
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus. Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue, Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: - Plastic and Reconstructive Surgery - Neurosurgery - Gastrointestinal and Affiliated Organ surgery - Urological Surgery - Orthopedic surgery - Gynecological Surgery - Thoracic surgery - Laparoscopic Surgery
    Device Description
    The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister. The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.
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    K Number
    K092022
    Device Name
    TISSU TRANS HARVEST TUBING
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    2009-08-17

    (42 days)

    Product Code
    KYZ
    Regulation Number
    880.6960
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K050797
    Device Name
    TISSU-TRANS
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    2005-07-13

    (106 days)

    Product Code
    KYZ, REQ
    Regulation Number
    880.6960
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired. Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.
    Device Description
    Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection. Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.
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    K Number
    K964855
    Device Name
    EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1997-03-04

    (90 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964334
    Device Name
    EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1996-12-09

    (39 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery.
    Device Description
    The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery. There is no modification in the proposed device and the predicate devices that alters safety and effectiveness. The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated.
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    K Number
    K963704
    Device Name
    MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1996-11-26

    (71 days)

    Product Code
    LYG
    Regulation Number
    890.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used in the treatment and management of muscle spasm and muscle tension.
    Device Description
    The proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.
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    K Number
    K962133
    Device Name
    EXPANDACELL INJECTO-PAK
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1996-08-01

    (59 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    administration of liquid medication and hydrating for the sinus
    Device Description
    Expandacell Injecto-Pak Foam Pack
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    K Number
    K960621
    Device Name
    EXPANDACELL INSTRUMENT WIPE
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1996-04-01

    (48 days)

    Product Code
    GEC, GER
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.
    Device Description
    The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.
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    K Number
    K960228
    Device Name
    EXPANDACELL INJECTO-PAK NASAL PACK
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1996-02-27

    (41 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHIPPERT MEDICAL TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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