BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KARL STORZ Flexible HD Cysto-Urethroscope System

    K Number: K212476 · Decision Sep 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    25
    Review Days
    28

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    Basic Information

    Device Name
    KARL STORZ Flexible HD Cysto-Urethroscope System
    K Number
    K212476
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America, Inc.
    Date Received
    August 6, 2021
    Decision Date
    September 3, 2021
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by Karl Storz Endoscopy America, Inc.

    K Number Device Name
    K240506 KARL STORZ Holders
    K223885 HOPKINS Telescopes
    K230359 KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-
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    K221004 HOPKINS Telescopes
    K222504 H1
    K213194 HD Mediastinoscope
    K221174 Telepack +
    K203198 KARL STORZ Metal Sterilization Trays
    K202272 HD Mediastinoscope
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