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510(k) Data Aggregation

    K Number
    K102887
    Device Name
    ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2011-05-16

    (228 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.
    Device Description
    The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.
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    K Number
    K082803
    Device Name
    COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2008-11-13

    (50 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUTANEOUS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.
    Device Description
    The Coaxial Accordion Stone Management Device consists of a film membrane attached onto a cannula with a removable handle.
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    K Number
    K052134
    Device Name
    CYSTOGLIDE DILATING INTRODUCER SHEATH
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2005-09-22

    (48 days)

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

    PERCUTANEOUS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to facilitate the dilation of urethral strictures and the introduction of catheters or instruments into the urethra. The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for use as a urethral dilator and as a guide for urological catheters or instruments and as a lubricious barrier between the urethral tissue and the catheter or instrument.
    Device Description
    The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a film, a sheath, a stabilizing hub and a dilator. The device can be front-loaded onto a urological guidewire.
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    K Number
    K042877
    Device Name
    MICROVERTER URETERAL ACCESS SHEATH
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2004-11-16

    (29 days)

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

    PERCUTANEOUS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.
    Device Description
    The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.
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    K Number
    K040519
    Device Name
    SLIP UROLOGY CATHETER
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2004-05-20

    (83 days)

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

    PERCUTANEOUS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SLIP Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device is indicated for providing increased lubricity during the catheter's advancement.
    Device Description
    The SLIP Urology Catheter consists of a catheter, a sheath, a snap ring, and a guide ring. The catheter is pre-loaded with a membrane sheath for increased lubricity.
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    K Number
    K040520
    Device Name
    SLIP UROLOGY INTRODUCER SHEATH
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2004-05-20

    (83 days)

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

    PERCUTANEOUS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
    Device Description
    The SLIP Urology Catheter consists of a sheath, pusher tube, a twist ring, and a guide ring. The pusher tube is pre-loaded with the sheath.
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