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

    ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES

    K Number: K973190 · Decision Nov 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    88

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    Basic Information

    Device Name
    ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
    K Number
    K973190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryomedical Sciences, Inc.
    Date Received
    August 25, 1997
    Decision Date
    November 21, 1997
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Cryomedical Sciences, Inc.

    K Number Device Name
    K011073 CRYOPLAN SYSTEM
    K982055 ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
    K980668 CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
    K980670 CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
    K970995 CMS CRYOLITE
    K964336 CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
    K953637 CMS ACCUPROBE 550/530
    K952895 CMS URETHRAL WARMER
    K904421 CMS ONCOPROBE (TM)