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

    ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)

    K Number: K873619 · Decision Jan 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    29
    Review Days
    128

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    Basic Information

    Device Name
    ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)
    K Number
    K873619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Arthropedics, Inc.
    Date Received
    September 8, 1987
    Decision Date
    January 14, 1988
    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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    Other Clearances by Arthropedics, Inc.

    K Number Device Name
    K873655 MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
    K873653 MONOPOLAR CAUTERY BLADE TIP #TM-1701
    K873654 MONOPOLAR CAUTERY CONICAL TIP #TM-1702
    K873387 VIDEO ARTHROSCOPE, 1.7MM X 55 MM
    K873504 CUP BIOPSY FORCEPS, RIGHT
    K872533 THE CART
    K873501 SCISSOR, LEFT
    K873502 SCISSOR, RIGHT
    K873512 SERRATED GRASPING FORCEPS, RIGHT
    K873710 MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350
    Search all 29 clearances from Arthropedics, Inc. →