BEUDAMED
    Product Code: SCB FDA class 2 21 CFR 876.1550

    Deflation Needle For Removal Of Intragastric Balloon

    Gastroenterology, Urology

    A deflation needle for removal of an intragastric balloon is a prescription device intended to puncture and drain fluid from an intragastric balloon so that the deflated balloon can be removed endoscopically, enabling safe removal of intragastric weight-loss balloons without surgical intervention. It is classified as FDA Class II (510(k) required) under regulation 876.1550 in the Gastroenterology and Urology specialty, with product code SCB. The device is not an implant and does not support life-sustaining functions.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    SCB
    Device Class
    FDA class 2
    Regulation Number
    876.1550
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.