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510(k) Data Aggregation

    K Number
    K190492
    Device Name
    Peralta Stone Removal Catheter
    Manufacturer
    Calcula Technologies, Inc
    Date Cleared
    2019-07-18

    (140 days)

    Product Code
    FFL, EZN
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
    Device Description
    The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.
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    K Number
    K172299
    Device Name
    Accordion Piccolo Stone Management Device
    Manufacturer
    THS International, Inc. d/b/a Accordion Medical
    Date Cleared
    2017-09-19

    (50 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
    Device Description
    The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.
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    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?
    Product Code :

    FFL

    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?
    Product Code :

    FFL

    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
    K052048
    Device Name
    ACCORDION
    Manufacturer
    PERCUTANEOUS SYSTEMS, INCORPORATED
    Date Cleared
    2005-09-13

    (46 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
    Device Description
    The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.
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    K Number
    K012581
    Device Name
    REPROCESSED STONE RETRIEVAL BASKETS
    Manufacturer
    STERILMED, INC.
    Date Cleared
    2002-02-14

    (189 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.
    Device Description
    SterilMed's reprocessed stone retrieval baskets consist of a handle, shaft/sleeve, and a wire basket which serves as the stone capturing mechanism. They come in diameters ranging from 1.9 French to 8.0 French, and lengths ranging from 70 cm to 220 cm. The baskets are available in 3 to 8 wire configurations and flat or helical wire designs.
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    K Number
    K972091
    Device Name
    AMS FOREIGN BODY EXTRATOR
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-08-29

    (86 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.
    Device Description
    The AMS Foreign Body Extractor is made of stainless steel and consists of an obturator, sheath, grasper, seals, handle, security clip, telescope stabilizers and ACMI adaptor ring. The AMS Foreign Body Extractor Accessory Kit contains replacement security clip, telescope stabilizers, ACMI adaptor ring, and seals. To facilitate insertion into the urethra and bladder, the obturator is placed inside the sheath. Once inside the bladder, the obturator is removed and the grasper is placed within the lumen of the sheath. The handle is then attached and the telescope inserted into the sheath. The grasping jaws are operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body.
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    K Number
    K970489
    Device Name
    COMEG ENDOSCOPY GRASPING FORCEPS
    Manufacturer
    COMEG ENDOSCOPY
    Date Cleared
    1997-03-19

    (37 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.
    Device Description
    The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.
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    K Number
    K962387
    Device Name
    OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1996-07-31

    (41 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961248
    Device Name
    BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1996-05-28

    (57 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    FFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard® Platinum Class™ Ureteroscopic 3 French Flat Wire Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi. Bard® Platinum Class™ Ureteroscopic 3 French High-Torque Helical Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi. Bard® Platinum Class™ Ureteroscopic 3 French Grasping Forceps is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.
    Device Description
    The Bard® Platinum Class™ 3 French Ureteroscopic Instrument product line consists of three separate instruments or stone dislodgers: the Flat Wire Stone Basket, the High-Torque Helical Stone Basket, and the Grasping Forceps. These instruments are each constructed of three main assemblies: a handle assembly, shaft assembly, and stone capture mechanism consisting of an expandable basket or grasping forceps assembly. Stone dislodgers (baskets or grasping forceps) may be used in the removal of renal and ureteral stones and calculi by inserting the stone basket or grasping forceps (while in a closed position) through the working channel of an endoscope and into the ureter or renal pelvis. The tip of the basket or forceps is advanced past the stone and the expandable basket or forceps is opened, manipulated and closed around the stone, thereby capturing it for removal. Once the stone has been captured, the basket or forceps should be partially closed to keep the stone from dislodging while the device and endoscope are being withdrawn. The devices have a 3 Fr. outer diameter shaft size and each is available in three different lengths, 70cm, 90cm and 115cm.
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