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

    MITEK ABSORBABLE ANCHOR

    K Number: K941599 · Decision Oct 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    31
    Review Days
    571

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    Basic Information

    Device Name
    MITEK ABSORBABLE ANCHOR
    K Number
    K941599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Mitek Surgical Products, Inc.
    Date Received
    April 1, 1994
    Decision Date
    October 24, 1995
    Product Code
    MNV
    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
    MNV Strip, Dialysate Ph Indicator

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    Other Clearances by Mitek Surgical Products, Inc.

    K Number Device Name
    K953560 MITEK THREADED ANCHOR (FASTIN)
    K953877 MITEK GII ANCHOR
    K936311 MITEK MINI ANCHOR
    K944051 ABSORBALBE ANCHOR
    K950070 MITEK TOGGLE ANCHOR(TM)
    K944936 MITEK G III ANCHOR, MITEK LS ANCHOR
    K945203 MITEK THRADED ANCHOR (MTA)
    K934366 MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
    K931782 MITEK GIII ANCHOR
    K931253 QUICKANCHOR II
    Search all 31 clearances from Mitek Surgical Products, Inc. →