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

    READI-STRAND; MODEL PSSTRAND

    K Number: K020337 · Decision Jul 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    15
    Review Days
    178

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    Basic Information

    Device Name
    READI-STRAND; MODEL PSSTRAND
    K Number
    K020337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Worldwide Medical Technologies, LLC
    Date Received
    February 1, 2002
    Decision Date
    July 29, 2002
    Product Code
    KXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXK Source, Brachytherapy, Radionuclide

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    Other Clearances by Worldwide Medical Technologies, LLC

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    K022389 READI-LOAD SYSTEM, MODEL PSS 1820RL
    K020641 SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
    K020867 BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
    K991344 WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
    K981889 WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
    K982097 WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
    K981470 WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
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