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

    AMSURE HYDROPHILIC LATEX FOLEY CATHETER

    K Number: K091699 · Decision Aug 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    28
    Review Days
    61

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AMSURE HYDROPHILIC LATEX FOLEY CATHETER
    K Number
    K091699
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amsino International, Inc.
    Date Received
    June 10, 2009
    Decision Date
    August 10, 2009
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EZL), ordered by most recent decision date.

    Rusch SoftSimplastic Foley Catheters

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Silicone Urethral Catheter (Silicone Urethral Catheter)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    InnoCare Specialty Foley Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Rüsch Latex Gold Foley Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TraumaGuard Intra-abdominal Pressure Sensing System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Folysil Silicone Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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
    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. →