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510(k) Data Aggregation

    K Number
    K240506
    Device Name
    KARL STORZ Holders
    Manufacturer
    KARL STORZ Endoscopy America, Inc
    Date Cleared
    2024-10-22

    (244 days)

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

    KARL STORZ Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
    Device Description
    The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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    K Number
    K223885
    Device Name
    HOPKINS Telescopes
    Manufacturer
    Karl Storz Endoscopy America, Inc.
    Date Cleared
    2023-09-14

    (261 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Karl Storz Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.
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    K Number
    K230359
    Device Name
    KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-
    Manufacturer
    KARL STORZ Endoscopy America, Inc
    Date Cleared
    2023-06-23

    (133 days)

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

    KARL STORZ Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ suction and irrigation system (consisting of handle and suction/irrigation tubes, cannulae or needles) is intended for use by qualified surgeons to provide suction and/or irrigation function to help flush or remove blood, fluids, and tissue debris from the operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.
    Device Description
    The devices in the KARL STORZ Suction and Irrigation System are manually operated, reusable surgical devices consisting of handle, suction/irrigation tubes, cannulae or needles. The handle is intended to be used in combination with suction/irrigation cannulae and tubing and controls the suction and irrigation. Enabled by the handle with stop cock valve, the regulation of the irrigated quantity of fluids via the tubes, or rather the quantity of aspirated fluid (e.g., blood, fluids, and tissue debris) into or out of the patient is performed. Cannula and needle: Enabled by the pointed distal end, both puncture and injection/extraction cannulae and needles, perform puncturing of target organs or tissues and injecting fluids into operating site i.e. extracting blood or fluids from them. The prerequisite for suction is either a vacuum powered suction wall apparatus or a pump, which serve as impulse for the suction. The proximal end of the tube set is connected to the vacuum or pump. Either a pump is required as impulse for irrigation or the natural force of gravity, i.e., by positioning the flush bag at the appropriate height.
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    K Number
    K221893
    Device Name
    KARL STORZ Bipolar Resectoscopes with HF Cable
    Manufacturer
    KARL STORZ Endoscopy America, Inc
    Date Cleared
    2023-03-17

    (261 days)

    Product Code
    FJL, FAS, FDC, GEI, HIH
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARL STORZ Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures. The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures. The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures. Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures. Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures Indications for Use in UROLOGY and GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
    Device Description
    Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology) or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator, working element and HF electrode.
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    K Number
    K221004
    Device Name
    HOPKINS Telescopes
    Manufacturer
    KARL STORZ Endoscopy America, Inc.
    Date Cleared
    2022-12-20

    (259 days)

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

    KARL STORZ Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
    Device Description
    The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.
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    K Number
    K222504
    Device Name
    H1
    Manufacturer
    Karl Storz Endoscopy America, Inc.
    Date Cleared
    2022-11-10

    (84 days)

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

    Karl Storz Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.
    Device Description
    The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.
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    K Number
    K213194
    Device Name
    HD Mediastinoscope
    Manufacturer
    Karl Storz Endoscopy America, Inc.
    Date Cleared
    2022-06-23

    (267 days)

    Product Code
    EWY
    Regulation Number
    874.4720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Karl Storz Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
    Device Description
    The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.
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    K Number
    K221174
    Device Name
    Telepack +
    Manufacturer
    KARL STORZ Endoscopy America, Inc
    Date Cleared
    2022-05-13

    (18 days)

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

    KARL STORZ Endoscopy America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.
    Device Description
    The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.
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    K Number
    K212458
    Device Name
    Flexible Video-Uretero-Renoscope SSU System
    Manufacturer
    KARL STORZ Endoscopy America
    Date Cleared
    2022-01-20

    (168 days)

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

    KARL STORZ Endoscopy America

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SSU Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
    Device Description
    The videoscopes in the modified Flexible Video-Uretero-Renoscope SSU System are sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
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    K Number
    K212656
    Device Name
    Flexible Intubation Video Endoscope – Sterile (FIVE-S)
    Manufacturer
    KARL STORZ Endoscopy America
    Date Cleared
    2021-12-29

    (128 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARL STORZ Endoscopy America

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexible Intubation Video Endoscope - Sterile (FIVE-S) are intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor. E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
    Device Description
    The Flexible Intubation Video Endoscope - Sterile (FIVE-S) is a sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging sensor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
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