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

    R-MED DISPOSABLE PLUG

    K Number: K942411 · Decision Mar 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    9
    Review Days
    315

    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
    R-MED DISPOSABLE PLUG
    K Number
    K942411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R-Med, Inc.
    Date Received
    May 20, 1994
    Decision Date
    March 31, 1995
    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 R-Med, Inc.

    K Number Device Name
    K001236 RIZA BAND STRETCHER (RBS)-60000
    K953360 R-MED ABDOMINAL WALL ELEVATOR
    K954882 RIZA-RIBE NEEDLE (MODIFICATION)
    K953441 RIZA-RIBE NEEDLE
    K950108 R-MED MINI-RETRACTOR
    K945637 R-MED MOTORIZED LAPAROSCOPIC HANDLE
    K943818 MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS
    K935031 RIZA-RIBE NEEDLE