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

    AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE

    K Number: K000117 · Decision Apr 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
    K Number
    K000117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avid Medical, Inc.
    Date Received
    January 14, 2000
    Decision Date
    April 13, 2000
    Product Code
    HEE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEE Set, Anesthesia, Paracervical

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    Other Clearances by Avid Medical, Inc.

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    K001731 AVID-NIT LOSS OF RESISTANCE SYRINGE