BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    LIGHTING SOURCE SYSTEM

    K Number: K923656 · Decision Sep 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    787

    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
    LIGHTING SOURCE SYSTEM
    K Number
    K923656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Galenica Enterprises, Inc.
    Date Received
    July 13, 1992
    Decision Date
    September 8, 1994
    Product Code
    HIC
    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
    HIC Speculum, Vaginal, Nonmetal, Fiberoptic

    Similar 510(k) Clearances

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

    PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY

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

    NEW LENGTH SUGITA APPLIERS

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

    CENTURION VAGINAL SPECULUM

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

    SPECULITE DISPOSABLE VAGINAL LIGHT

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

    Other Clearances by Galenica Enterprises, Inc.

    K Number Device Name
    K896383 DISPOSABLE EXTERNAL CLAMPS
    K883283 DISPOSABLE AMNIOTOME
    K861017 GALENICA'S DISPOSABLE ANOSCOPES
    K841909 VAGINAL SPECULUM - DISPOSABLE