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

    GRAVESPEC

    K Number: K935636 · Decision Mar 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    6
    Review Days
    122

    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
    GRAVESPEC
    K Number
    K935636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adept-Med Intl., Inc.
    Date Received
    November 23, 1993
    Decision Date
    March 25, 1994
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

    Similar 510(k) Clearances

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

    JFord Speculum Sleeve™

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

    BRELLA-SPEC(TM) VAGINAL SPECULUM

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

    IOB DISPOSABLE SPECULUM

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

    CLEARSPEC SINGLE USE VAGINAL SPECULUM

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

    SPECULUM, VAGINAL, NONMETAL

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

    KOLPLUX SYSTEM

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

    Other Clearances by Adept-Med Intl., Inc.

    K Number Device Name
    K893871 GOOTT BALFOUR BLADE
    K893869 GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)
    K893870 ADAMS BREAST IMPLANT PROTECTOR
    K870809 MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206
    K802806 VISECERA RETAINER