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

    ACUFEX ENDOBUTTON TAPE

    K Number: K952535 · Decision Feb 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    78
    Review Days
    252

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    Basic Information

    Device Name
    ACUFEX ENDOBUTTON TAPE
    K Number
    K952535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Acufex Microsurgical, Inc.
    Date Received
    June 1, 1995
    Decision Date
    February 8, 1996
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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    Other Clearances by Acufex Microsurgical, Inc.

    K Number Device Name
    K961555 ACUFEX TAG BIOABSORBABLE ANCHORS
    K961853 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
    K954246 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
    K953276 ACUFEX TAG DELIVERY SYSTEM
    K953459 ACUFEX TAG ANCHOR
    K941740 ACUFEX ROTATOR CUFF FIXATION BUTTON
    K944500 ACUFEX PATELLAR BONE BLOCK SIZER
    K951859 ACUFEX ENDOBUTTON PACK
    K946346 ACUFEX TAG(R) BIOABSORBABLE ANCHORS
    K941709 ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
    Search all 78 clearances from Acufex Microsurgical, Inc. →