BEUDAMED
    Product Code: FDC FDA class 2 21 CFR 876.1500

    Resectoscope, Working Element

    Gastroenterology, Urology

    The Resectoscope Working Element (product code FDC) is the active working component of a resectoscope assembly, housing the electrode and its movement mechanism, used for transurethral resection of prostatic or bladder tissue. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

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    510(k)s
    11
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    7
    Years Active
    26

    Basic Information

    Product Code
    FDC
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K021166 ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
    K992141 OLYMPUS WORKING ELEMENT FOR PROBES
    K991426 MAHE INSTRUMENTS
    K942626 CONTINUOUS FLOW BIOPSY PROBE
    K933962 GM CONTINUOUS FLOW BIOPSY PROBE
    K895643 MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
    K894363 UROPUMP* FLUID MANAGEMENT SYSTEM
    K842997 LASER RECTOSCOPE SET 784
    K760184 ELEMENT, WORKING
    K760182 SHEATH, RESECTOSCOPE
    K760174 ADAPTER, RESECTOSCOPE

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.