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

    HGM, INC. LASERCATH (STERILE)

    K Number: K860357 · Decision Apr 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    23
    Review Days
    67

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    Basic Information

    Device Name
    HGM, INC. LASERCATH (STERILE)
    K Number
    K860357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hgm, Inc.
    Date Received
    January 30, 1986
    Decision Date
    April 7, 1986
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    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
    LNK Laser For Gastro-Urology Use

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    Other Clearances by Hgm, Inc.

    K Number Device Name
    K950120 SMART PLUG
    K931072 HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
    K931784 HGM ILLUMINATING IMAGING ENDOCULAR PROBE
    K933333 HGM SCANMAN PLUS
    K931499 Q-11 OPHTHALMIC LASER
    K925663 HGM ASPIRATING ENDOOCULAR(TM) PROBE
    K930543 E-25 KRYPTON ION LASER (SURGICA K5)
    K880908 MODEL PC ARGON LASER
    K873773 ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER
    K872630 ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
    Search all 23 clearances from Hgm, Inc. →