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

    SURGI-KIT

    K Number: K770590 · Decision Apr 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    19
    Review Days
    17

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    Basic Information

    Device Name
    SURGI-KIT
    K Number
    K770590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ethox Corp.
    Date Received
    March 28, 1977
    Decision Date
    April 14, 1977
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Ethox Corp.

    K Number Device Name
    K040286 ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
    K031195 CUF-COVER (TM)
    K962850 TUM-E-VAC
    K935633 NO-MES
    K921946 TUM-E-VAC BITE BLOCK
    K885220 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
    K894927 SURGI SQUEEZ
    K883977 SURGI-CUF STERILE/NON-STERILE DISPOSABLE
    K860599 ETHOX LAVAGE TUBE
    K844988 ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
    Search all 19 clearances from Ethox Corp. →