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

    ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES

    K Number: K954052 · Decision Nov 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    27
    Review Days
    69

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    Basic Information

    Device Name
    ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
    K Number
    K954052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    T. Korossurgical Instruments Corp.
    Date Received
    August 29, 1995
    Decision Date
    November 6, 1995
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    K953998 DISCETOME TISSUE ASPIRATOR
    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
    K931259 ENDOSCOPIC OR THORASCOPIC FORCEPS
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