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

    MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN

    K Number: K862227 · Decision Aug 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    23
    Review Days
    69

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
    K Number
    K862227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Hgm, Inc.
    Date Received
    June 11, 1986
    Decision Date
    August 19, 1986
    Product Code
    HHR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHR Laser, Surgical, Gynecologic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HHR), ordered by most recent decision date.

    ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODEL 5050 SURGILASER FOR OB-GYN USE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GL-35 COLPOSCOPIC LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LASER CANNISTER FILTER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    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. →