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510(k) Data Aggregation

    K Number
    K182144
    Device Name
    Bi-Flex Evo
    Manufacturer
    Date Cleared
    2018-09-07

    (30 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Promepla Sam

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiFlex Evo is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
    Device Description
    The Bi-Flex Evo Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes,10/12 and 12/14 FR, and two lengths, 35 and 45 cm.
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    K Number
    K173734
    Device Name
    RocaJJ Soft Stents
    Manufacturer
    Date Cleared
    2018-03-12

    (96 days)

    Product Code
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Promepla SAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Roca.IJ Soft Stents are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic techniques. The stents are not intended as a permanent indwelling devices, it is recommended that: - The indwelling time not exceed 6 days when the device is used with the removal string; - The indwelling time not exceed 365 days when the device is used without the removal string.
    Device Description
    The RocaJJ Soft Stents system is a set consisting of a tubular double pigtail stent made up of flexible radiopaque polyurethane, with a polypropylene-monofilament suture loop in order to facilitate the extraction of the ureteral stent. The devices may include a pusher with a radiopaque tip, and a guidewire. Otherwise, these sets may include only a pusher. The RocaJJ Soft Stents are from 4.8 to 8.0 Fr in diameter and from 24 to 30 cm in specified length.
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    K Number
    K152278
    Device Name
    ENDOFLOW II - Irrigation, Warming and Suction System
    Manufacturer
    Date Cleared
    2016-02-09

    (181 days)

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

    PROMEPLA SAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.
    Device Description
    The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv. The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction. The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity. The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function. The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.
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    K Number
    K140441
    Device Name
    BI-FLEX URETERAL ACCESS SHEATH
    Manufacturer
    Date Cleared
    2014-06-17

    (116 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEPLA SAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
    Device Description
    The Bi-Flex Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR, and two lengths, 35 and 45 cm.
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    K Number
    K120160
    Device Name
    ROCAMED ROCAUS PLATINUM
    Manufacturer
    Date Cleared
    2012-05-14

    (116 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEPLA SAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
    Device Description
    The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.
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    K Number
    K071421
    Device Name
    PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
    Manufacturer
    Date Cleared
    2007-10-04

    (135 days)

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

    PROMEPLA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.
    Device Description
    The Promepla Intravascular administration and extension sets contain components that are commonly found in this category of IV sets. The IV Administration (pump tube) Set belongs to a full line of intravenous fluid delivery sets. It is an infusion set intended to deliver fluids, medications, blood and blood products, using continuous or intermittent delivery through clinically acceptable routes of administration (e.g. intravenous, intra-arterial, subcutaneous, epidural, enteral or irrigation of fluid spaces). An optional component, a flow controller allows the use with a peristaltic pump. The Extension Set device is a triple lumen peripheral set with two detachable long lines, belonging to a family of extension tubing sets. This device uses a main gravity drip line, plus the two long extension limbs. It is a connector system, which has anti free-flow valves and line clamps, which are common in intravascular extension sets on the market. The extension set allows IV fluids to be given simultaneously by way of the same connector. Both the IV Administration Set and Extension Set are provided sterile (by Eto) and are for single use only. They are intended only for use by trained professionals in a clinic or hospital environment.
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