BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MINOR LAP SET

    K Number: K921732 · Decision Jun 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    796

    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
    MINOR LAP SET
    K Number
    K921732
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medikmark, Inc.
    Date Received
    April 10, 1992
    Decision Date
    June 15, 1994
    Product Code
    KOH
    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
    KOH Instrument, Manual, General Obstetric-Gynecologic

    Similar 510(k) Clearances

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

    KSEA CHARDONNES MORCELLATION KNIFE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    C-SECTION PACK

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    NEWPORT LATERAL VAGINAL RETRACTOR

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    NEEDLE EXTENSIONS

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ZEPPELIN SCISSORS

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology
    View all

    Other Clearances by Medikmark, Inc.

    K Number Device Name
    K953474 IV START KIT
    K923960 UPPER EXTERMITY DRAPE KIT
    K921730 C-SECTION PACK
    K921733 TRACHEOSTOMY CARE TRAY
    K920339 DRESSING CHANGE TRAY
    K920341 LACERATION TRAYS
    K920340 SUTURE REMOVAL KIT