Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K232370
    Device Name
    Percutaneous Nephroscope System
    Manufacturer
    Karl Storz SE & Co. Kg
    Date Cleared
    2024-05-01

    (267 days)

    Product Code
    FGA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Percutaneous System for adults The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults. Percutaneous System for adults and pediatrics The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
    Device Description
    The Percutaneous Nephroscope System consists of the following: - Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes - HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL) - Operating Sheaths - One-Step Dilators - Telescope Bougie Set - Hollow Obturator and Fascial Dilator Applicators - Biopsy and Grasping forceps - Scissors - Knives - Insertion Aid - Laser Hand Instrument - Suction tube - Adaptors - Luer-Lock tube connectors
    Ask a Question
    K Number
    K151308
    Device Name
    Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Date Cleared
    2016-02-09

    (267 days)

    Product Code
    FGA, FEC, FED
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters. The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
    Device Description
    The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set". Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application. In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges. The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.
    Ask a Question
    K Number
    K072594
    Device Name
    GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
    Manufacturer
    GYRUS ACMI, INC.
    Date Cleared
    2007-12-13

    (90 days)

    Product Code
    FGA, FEC, FED
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® Smith™ Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.
    Device Description
    The Gyrus ACMI® IPN-2505. Invisio® Smith™ Percutaneous Nephroscope (referred to hereafter as the IPN-2505) is a rigid endoscope that incorporates CMOS (complimentary metal oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the IDC-1500 Camera Control Unit (CCU). The IPN-2505 can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The IPN-2505 uses an IDC-1500 CCU that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
    Ask a Question
    K Number
    K994223
    Device Name
    NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2000-06-05

    (173 days)

    Product Code
    FGA, FEC, FED, FFL
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nephroscope, with its accessories, is used, with suction, for the disintegration and removal / extraction of kidney and bladder stones. The stones are removed, under endoscopic control, through percutaneous or transurethal passages, in conjuction with intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotriptors. For diagnosis and therapy with endoscopic accessories in the upper and lower urogenital tract when performed by trained and qualified medical personnel.
    Device Description
    The universal nephroscope has a reduced sheath diameter and an expanded working channel to accommodate auxiliary instruments and irrigation. The submitted nephroscope design has been modified to optimize user handling. The submitted nehproscope can be held by the elongated right angled light connected which has been designed with a recessed grip and a thumb ring. An automatic valve for instrument insertion and an automatic locking mechanism between the endoscope and sheath is part of the submitted design. Accessory instruments have been adapted to the longer nephroscope.
    Ask a Question

    Page 1 of 1