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510(k) Data Aggregation

    K Number
    K152538
    Device Name
    JRP Wound Spreader
    Manufacturer
    J.R. PARKER, LLC
    Date Cleared
    2016-04-13

    (222 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JRP Wound Spreader is a non-invasive superficial wound retractor with integrated guard that is used for wound care and positioning of small superficial wounds in the skin of up to 1/4" in width, 1/4" in depth and 1/2" in length.
    Device Description
    The JRP Wound Spreader is a manually operated handheld non-invasive superficial wound retractor with an integrated guard that can accommodate a needleless syringe for the purpose of facilitating the retraction, observing the wound and flushing of small superficial wounds in the skin if deemed necessary. The JRP Wound Spreader consists of an array of four small tensioning fingers, which can be positioned on the skin astride a small superficial wound or incision.
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    K Number
    K151104
    Device Name
    OTELO LL
    Manufacturer
    SPINEART
    Date Cleared
    2016-01-06

    (257 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue.
    Device Description
    The OTELO®LL Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The OTELO®LL Retractor System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.
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    K Number
    K132645
    Device Name
    THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
    Manufacturer
    MEDTRONIC, INC.
    Date Cleared
    2013-10-04

    (42 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ThoraTrakTM minimally invasive cardiac surgery (MICS) retractor system is intended to provide surgical access for minimally invasive cardiothoracic procedures, including minimally invasive coronary artery bypass grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.
    Device Description
    The ThoraTrak™ minimally invasive cardiac surgery (MICS) retractor system is designed for use with a minimally invasive thoracotomy, an incision in the chest wall into the pleural space, for procedures that include Coronary Artery Bypass Grafting (CABG) and Left Internal Mammary Artery (LIMA) harvesting. It consists of a retractor rack, 2 sets of LIMA blades, 4 sets of thoracotomy blades, and 2 extended mount blades. The retractor rack and blades are chromecoated stainless steel. They are non-sterile, nonpyrogenic, and reusable.
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    K Number
    K071775
    Device Name
    DASH
    Manufacturer
    EZSURGICAL
    Date Cleared
    2007-08-07

    (39 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DASH™ is a deformable shape memory padded retractor, which is intended to retain or hold back organs and tissue in the course of surgical procedure. At the same time it serves as means of cushioning and absorption to the surgical area.
    Device Description
    The DASH™ is a deformable shape memory padded retractor
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    K Number
    K050256
    Device Name
    APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2005-04-26

    (82 days)

    Product Code
    GAD, KNA
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.
    Device Description
    The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable abdominal retractor consisting of two flexible plastic rings connected by a sleeve of soft, high yield strength, clear plastic film. The internal ring has a circular cross-section (o-ring) and the external ring has a cruciform cross-section (quad-ring). The inner diameter of the internal o-ring limits the radius of abdominal retraction. The diameter of the external quad-ring is the same as the diameter of the internal o-ring and the sleeve. When completely unwound, the height of the cylinder is 10.6 inches. When the quad ring is rolled down, the sleeve is wrapped around the circumference of the ring reducing the height of the sleeve by 1.5 inches per rotation. Because the sleeve film is radially unyielding, the reduction in height causes the radial retraction of the incision site.
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    K Number
    K043602
    Device Name
    QUADRANT RETRACTOR SYSTEM
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Date Cleared
    2005-02-23

    (56 days)

    Product Code
    GAD, FSZ, NBH
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAST QUADRANT™ Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive approach. The MAST QUADRANT™ Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANT™ Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.
    Device Description
    The MAST QUADRANT™ Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The MAST QUADRANT™ System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.
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    K Number
    K001339
    Device Name
    MRI FASTSYSTEM RETRACTOR SYSTEM
    Manufacturer
    OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
    Date Cleared
    2000-05-17

    (20 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980588
    Device Name
    CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
    Manufacturer
    CLARUS MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-08-18

    (182 days)

    Product Code
    GAD, KOG
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.
    Device Description
    The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine. This will provide as access point to apply surgical techniques through the tubular retractor under endoscopic visualization. These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(****) MicroEndoscopic Discectomy System" The comparisons of these devices are shown in Table I These retractors and dilators will be sold as a kit (See Kit Certification- Attachment F). Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).
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    K Number
    K963006
    Device Name
    SCION SAPHENOUS VEIN HARVESTING SYSTEM
    Manufacturer
    SCION INTERNATIONAL, INC.
    Date Cleared
    1996-09-20

    (49 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAD

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

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