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

    SURGICLA INSTRUMENT KIT

    K Number: K946019 · Decision Mar 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    8
    Review Days
    98

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    Basic Information

    Device Name
    SURGICLA INSTRUMENT KIT
    K Number
    K946019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Action Industries, Inc.
    Date Received
    December 12, 1994
    Decision Date
    March 20, 1995
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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    Other Clearances by Medical Action Industries, Inc.

    K Number Device Name
    K042526 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
    K042527 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    K022948 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    K923846 BURN DRESSING
    K884826 GAUZE SPONGE
    K810685 SUTURE REMOVAL KIT
    K810184 LAPAROTOMY SPONGE