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

    RIGID CULDOSCOPE AND ACCESSORIES

    K Number: K980972 · Decision Jun 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    17
    Applicant Total
    6
    Review Days
    88

    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
    RIGID CULDOSCOPE AND ACCESSORIES
    K Number
    K980972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1640
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circon Corp.
    Date Received
    March 16, 1998
    Decision Date
    June 12, 1998
    Product Code
    HEW
    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
    HEW Culdoscope (And Accessories)

    Similar 510(k) Clearances

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

    GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

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

    Advincula Delineator Uterine Manipulator

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

    Transvaginal Access Platform

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

    Advincula Delineator Uterine Manipulator

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

    ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

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

    GelPOINT Transvaginal Access Platform

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

    Other Clearances by Circon Corp.

    K Number Device Name
    K992544 TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
    K992126 CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
    K981611 SNAP-N-PEEL INTRODUCERS
    K973820 USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
    K964594 VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)