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

    MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP

    K Number: K896589 · Decision Dec 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
    K Number
    K896589
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Optik
    Date Received
    November 21, 1989
    Decision Date
    December 27, 1989
    Product Code
    LRZ
    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
    LRZ Screwdriver, Surgical

    Similar 510(k) Clearances

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

    1.1 SCREWDRIVERS

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

    STANDARD SCREW DRIVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
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    Other Clearances by Optik

    K Number Device Name
    K933776 OPTIK LAPAROSCOPE
    K926166 COAST VIDEO ENDOSCOPIC IMAGING SYSTEM
    K896404 TITAMED ANTWERP SYSTEM
    K894558 MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
    K894557 LIGHTSCOPE SET