BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COMFORT CATH CHOICE MALE EXTERNAL CATHETER

    K Number: K970966 · Decision Apr 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    12
    Review Days
    36

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    Basic Information

    Device Name
    COMFORT CATH CHOICE MALE EXTERNAL CATHETER
    K Number
    K970966
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sierra Laboratories, Inc.
    Date Received
    March 17, 1997
    Decision Date
    April 22, 1997
    Product Code
    EXJ
    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
    EXJ Device, Incontinence, Urosheath Type, Sterile

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    Other Clearances by Sierra Laboratories, Inc.

    K Number Device Name
    K962413 COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
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    K934266 COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
    K934052 ALPINE REUSABLE LEG BAGS
    K931156 CONE CATH
    K901000 URO TEX URINALS
    K883057 COMFORT CATH MALE EXTERNAL CATHETER
    K873039 MODEL 820 TOP=TRAK
    K832450 URO-TEX MALE EXTERNAL CATHETER
    K811887 SKIN STAPLE EXTRACTOR
    Search all 12 clearances from Sierra Laboratories, Inc. →