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

    STERILE VIDEO CAMERA COVER AND DRAPE

    K Number: K936086 · Decision Mar 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    7
    Review Days
    86

    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
    STERILE VIDEO CAMERA COVER AND DRAPE
    K Number
    K936086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micromedical Devices, Inc.
    Date Received
    December 21, 1993
    Decision Date
    March 17, 1994
    Product Code
    KXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KXK Source, Brachytherapy, Radionuclide

    Similar 510(k) Clearances

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

    OncoPatch

    FDA 510(k)
    FDA Class 2 ·Radiology

    IsoSphere

    FDA 510(k)
    FDA Class 2 ·Radiology

    RadianceTx Radionuclide Brachytherapy Source

    FDA 510(k)
    FDA Class 2 ·Radiology

    GammaTile

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

    FDA 510(k)
    FDA Class 2 ·Radiology

    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Micromedical Devices, Inc.

    K Number Device Name
    K043287 PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
    K936195 LAPAROSCOPES
    K936155 ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA
    K936097 VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL
    K850791 MDI 2000 - PULSE GENERATOR
    K834262 TRANS-PACE