BEUDAMED
    Product Code: NSI FDA class 2 21 CFR 876.1300

    System, Imaging, Esophageal, Wireless, Capsule

    Gastroenterology, Urology

    The Wireless Capsule Esophageal Imaging System is a disposable, ingestible capsule designed to acquire video images of the esophagus, transmitting the acquired images via RF communication to a data recorder worn outside the body. Unlike small bowel capsule endoscopy systems, this device is specifically intended for visualization of the esophagus. It is an FDA Class 2 device regulated under 21 CFR 876.1300 in the Gastroenterology and Urology specialty, with product code NSI, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.

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    510(k)s
    7
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    13

    Basic Information

    Product Code
    NSI
    Device Class
    FDA class 2
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K180171 PillCam Patency System
    K090557 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
    K071153 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
    K060805 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
    K052184 GIVEN DIAGNOSTIC SYSTEM
    K042960 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
    K041149 GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.