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

    OPTI-POINT

    K Number: K884781 · Decision Jan 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    8
    Review Days
    58

    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
    OPTI-POINT
    K Number
    K884781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Plastic Injectors, Inc.
    Date Received
    November 15, 1988
    Decision Date
    January 12, 1989
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

    Similar 510(k) Clearances

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

    SIRIUS Endoscope System (PR-SI-1230)

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

    i-Cut

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

    SIRIUS Endoscope System

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

    Video Endoscopy System, 3D Video Endoscopy System

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

    Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

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

    SurroundScope System

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

    Other Clearances by Plastic Injectors, Inc.

    K Number Device Name
    K863423 CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
    K863374 CODE-A-WELL SERIES 1-600, 1-625
    K844058 CODE-A-WALL SERIES 1-250 INOCULUM TRAY
    K842848 CODE-A-WELL 350 MICROTITRATION STRIPS
    K841632 CODE-A-WELL SERIES 200 PLATE
    K841937 CODE-A-WELL SERIES 300 PLATE
    K841390 CODE-A-WELL