BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SUCTION RETRACTOR

    K Number: K875289 · Decision Jan 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    27
    Review Days
    23

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    Basic Information

    Device Name
    SUCTION RETRACTOR
    K Number
    K875289
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    T. Korossurgical Instruments Corp.
    Date Received
    December 30, 1987
    Decision Date
    January 22, 1988
    Product Code
    GAD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAD Retractor

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    Other Clearances by T. Korossurgical Instruments Corp.

    K Number Device Name
    K001915 GRAFT MARKER RING
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    K954016 VIDEOSCOPE W/IRRIGATION SHEATH
    K953998 DISCETOME TISSUE ASPIRATOR
    K954052 ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
    K954014 PERCUTANEOUS DISCECTOMY CANNULA SYSTEM
    K935529 CERVICAL SELF-RETAINING RETRACTOR
    K926585 THOROCOSCOPY SELF-RETAINING RETRACTOR
    K931262 REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR
    K926583 REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR
    Search all 27 clearances from T. Korossurgical Instruments Corp. →