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

    AMSure Hydrophilic Intermittent Catheter

    K Number: K181445 · Decision Oct 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    28
    Review Days
    122

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    Basic Information

    Device Name
    AMSure Hydrophilic Intermittent Catheter
    K Number
    K181445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amsino International, Inc.
    Date Received
    June 1, 2018
    Decision Date
    October 1, 2018
    Product Code
    EZD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EZD Catheter, Straight

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    Other Clearances by Amsino International, Inc.

    K Number Device Name
    K252543 AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
    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
    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
    K171857 AMSure® Enteral Feeding Syringe with ENFit Tip
    Search all 28 clearances from Amsino International, Inc. →