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

    CAVERMAP SURGICAL AID

    K Number: K000507 · Decision Apr 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    10
    Review Days
    66

    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
    CAVERMAP SURGICAL AID
    K Number
    K000507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uromed Corp.
    Date Received
    February 15, 2000
    Decision Date
    April 21, 2000
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETN Stimulator, Nerve

    Similar 510(k) Clearances

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

    Evala Nerve Stimulator (EPNR002)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bioscope Neuromonitor Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EARP Nerve Cuff Electrode

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Disposable Laryngeal Electrodes

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Uromed Corp.

    K Number Device Name
    K010213 MODIFICATION TO CAVERMAP SURGICAL AID
    K010098 MODIFICATION TO CAVERMAP SURGICAL AID
    K993436 CAVERMAP SURGICAL AID
    K982226 UROMED BRACHYTHERAPHY IODINE-125 SOURCES
    K980717 UROMED SLING KIT
    K974600 UROMED PATCH
    K974137 UROMED NEEDLE GRASPER
    K970971 URO MED NERVE STIMULATOR
    K971992 UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)