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

    UNIVERSAL SURGICAL INSTRUMENT HOLDER

    K Number: K924713 · Decision May 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    26
    Review Days
    241

    Basic Information

    Device Name
    UNIVERSAL SURGICAL INSTRUMENT HOLDER
    K Number
    K924713
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Received
    September 18, 1992
    Decision Date
    May 17, 1993
    Product Code
    FWW
    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
    FWW Table, Operating-Room, Pneumatic

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    Other Clearances by T. KOROS SURGICAL INSTRUMENTS CORP.

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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
    K931259 ENDOSCOPIC OR THORASCOPIC FORCEPS
    Search all 26 clearances from T. KOROS SURGICAL INSTRUMENTS CORP. →