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

    SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE

    K Number: K925333 · Decision Sep 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    706

    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
    SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
    K Number
    K925333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aspen Labs
    Date Received
    October 21, 1992
    Decision Date
    September 27, 1994
    Product Code
    HGI
    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
    HGI Electrocautery, Gynecologic (And Accessories)

    Similar 510(k) Clearances

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

    IRIS Thermocoagulator and Digital Colposcope

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

    Liger Medical HTU-110

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

    FMWAND FERROMAGNETIC SURGICAL SYSTEM

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

    DOMAIN SURGICAL SYSTEM

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

    ENDOCERVICAL ELECTRODE # 2

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

    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

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

    Other Clearances by Aspen Labs

    K Number Device Name
    K970493 HYFRECATOR 2000
    K931215 HAND-TROL S
    K912046 SINGLE USE LEE ELECTRODE
    K905654 ELECTROSURGICAL UNIT WITH ACCESSORIES
    K904240 SINGLE USE LAPARSCOPIC ELECTRODE