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

    MITEK CONE WASHER

    K Number: K930675 · Decision Nov 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    19
    Applicant Total
    31
    Review Days
    273

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MITEK CONE WASHER
    K Number
    K930675
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4930
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mitek Surgical Products, Inc.
    Date Received
    February 9, 1993
    Decision Date
    November 9, 1993
    Product Code
    KGS
    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
    KGS Retention Device, Suture

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KGS), ordered by most recent decision date.

    SOFT TISSUE ANCHORING WASHERS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RBM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SUTURE LOCK

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACUFEX ROTATOR CUFF FIXATION BUTTON

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VENTROFIL TENSION RELIEF SUTURE SET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TRAY DOUGH

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Mitek Surgical Products, Inc.

    K Number Device Name
    K953560 MITEK THREADED ANCHOR (FASTIN)
    K953877 MITEK GII ANCHOR
    K936311 MITEK MINI ANCHOR
    K941599 MITEK ABSORBABLE 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
    Search all 31 clearances from Mitek Surgical Products, Inc. →