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

    FLEXIBLE SILICONE GELIHORN

    K Number: K920187 · Decision Oct 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    10
    Review Days
    283

    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
    FLEXIBLE SILICONE GELIHORN
    K Number
    K920187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bioteque America, Inc.
    Date Received
    January 14, 1992
    Decision Date
    October 23, 1992
    Product Code
    HHW
    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
    HHW Pessary, Vaginal

    Similar 510(k) Clearances

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

    Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

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

    CooperSurgical Milex® Pessaries

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

    Cntrl+ Bladder Support Pessary

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

    Reia pessary

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

    Yoni.Fit Bladder Support

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

    Uresta®

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

    Other Clearances by Bioteque America, Inc.

    K Number Device Name
    K041094 HSG CATHETER SET
    K020628 CURELLE, PREFERRED CURELLE, CUTEQ 2.5
    K013289 BIOTEQUE VAGINAL PESSARIES
    K003380 BIOTEQUE VAGINAL DILATOR
    K920633 PESSARY FLEXIBLE SILICONE NICHOLS
    K920747 PESSARY FLEXIBLE SILICONE DONUT RING
    K933628 CYTOLOGY BRUSH
    K933521 SPECULUM
    K920177 VERSA-VIAL