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

    KRYMED LIQUID NITROGEN CRYOJET

    K Number: K800335 · Decision Apr 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    7
    Review Days
    50

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    Basic Information

    Device Name
    KRYMED LIQUID NITROGEN CRYOJET
    K Number
    K800335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cryomedics, Inc.
    Date Received
    February 14, 1980
    Decision Date
    April 4, 1980
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Cryomedics, Inc.

    K Number Device Name
    K851152 MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
    K844431 YN CO2 LASER SYSTEM 30W
    K842888 DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
    K842959 MC-4000 CONSOLE & PROBES
    K842704 MT-700 MT-750 FT-350
    K801730 KRYMED SYSTEM 4001 TILT SCOPE