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

    PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

    K Number: K030813 · Decision May 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    4
    Review Days
    77

    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
    PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
    K Number
    K030813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Primary Care Solutions, Inc.
    Date Received
    March 14, 2003
    Decision Date
    May 30, 2003
    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 Primary Care Solutions, Inc.

    K Number Device Name
    K082330 PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
    K000265 PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
    K000266 PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION