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510(k) Data Aggregation

    K Number
    K231702
    Device Name
    WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
    Manufacturer
    OTU Medical Inc.
    Date Cleared
    2023-09-29

    (109 days)

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

    OTU Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
    Device Description
    WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope. WiScope®Digital Cystoscope System has the same intended use to the predicate device. Both devices use the same CMOS image sensor technology, i.e., an CMOS image sensor at the scope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system. In addition, they have same mechanical functions, e.g., a handle with a deflection control and a two-way deflectable insertion tube. WiScope®Single-Use Digital Flexible Cystoscope has the following 4 models: OTU-C300S: Standard Deflection Model for OTU-C300 series OTU-C300R: Reverse Deflection Model for OTU-C300 series OTU-C310S: Standard Deflection Model for OTU-C310 series OTU-C310R: Reverse Deflection Model for OTU-C310 series
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    K Number
    K220399
    Device Name
    WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
    Manufacturer
    OTU Medical Inc.
    Date Cleared
    2022-06-16

    (125 days)

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

    OTU Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.
    Device Description
    WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree. This system includes a single-use digital bronchoscope and an image system. - The image system OTU-A is the currently marketed in the United States by OTU Medical Inc. under 510(k) # K181977. - The single-use bronchoscope is comprised of a control body with an articulation lever, a suction connector, a suction button, and a working channel port, and a flexible insertion tube with an on-tip camera module and LED lighting source.
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    K Number
    K212202
    Device Name
    WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
    Manufacturer
    OTU Medical INC.
    Date Cleared
    2022-04-13

    (273 days)

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

    OTU Medical INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
    Device Description
    WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope and an image system OTU-A. The single-use cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source.
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    K Number
    K210579
    Device Name
    WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
    Manufacturer
    OTU Medical Inc.
    Date Cleared
    2021-07-22

    (146 days)

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

    OTU Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
    Device Description
    WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney, and the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site. This system includes a single-use digital ureteroscope/choledochoscope and an image system. WiScope® Single-Use Digital Flexible Ureteroscope/Choledochoscope is a modified version of the currently marketed WiScope Single-Use Digital Flexible Ureteroscope device that widen its application area from urinary system to bile ducts. Other than that, nothing has changed. The image system stays the same.
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    K Number
    K181977
    Device Name
    WiScope Digital Endoscope System
    Manufacturer
    OTU Medical Inc.
    Date Cleared
    2018-08-14

    (21 days)

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

    OTU Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
    Device Description
    WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform procedures in the urinary tract for diagnosis and treatment. This system includes a single-use digital ureteroscope and an image system. The single-use ureteroscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image system processes the images from the ureteroscope and outputs video signals to a display.
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