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

    AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE

    K Number: K061039 · Decision Jun 29, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    28
    Review Days
    76

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    Basic Information

    Device Name
    AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
    K Number
    K061039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amsino International, Inc.
    Date Received
    April 14, 2006
    Decision Date
    June 29, 2006
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Amsino International, Inc.

    K Number Device Name
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    K220230 AMSure Enteral Feeding Pump
    K220267 AMSafe NeuFlo Needleless Connector
    K213522 AMSafe Pre-Filled Normal Saline Flush Syringe
    K200051 PUGGLE Enteral Feeding Pump and Feeding Set
    K183473 AMSafe(R) Pre-Filled Normal Saline Flush Syringe
    K181445 AMSure Hydrophilic Intermittent Catheter
    K181423 AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
    K173665 AMSafe Sure-Lok Needle-Free Connector
    K181814 AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
    Search all 28 clearances from Amsino International, Inc. →