BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PillCam Patency System

    K Number: K180171 · Decision Mar 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    30
    Review Days
    45

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    Basic Information

    Device Name
    PillCam Patency System
    K Number
    K180171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging , Ltd.
    Date Received
    January 22, 2018
    Decision Date
    March 8, 2018
    Product Code
    NSI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NSI System, Imaging, Esophageal, Wireless, Capsule

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    Other Clearances by Given Imaging , Ltd.

    K Number Device Name
    K170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
    K170839 RAPID Web
    K151086 ManoScan System
    K153466 PillCam COLON 2 Capsule Endoscopy System
    K140284 GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
    DEN120023 GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
    K123864 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
    K103025 GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
    K101250 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
    K103088 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
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