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

    DYNACOR LUBRICATION GEL

    K Number: K103718 · Decision May 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    238
    Review Days
    140

    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
    DYNACOR LUBRICATION GEL
    K Number
    K103718
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medline Industries, Inc.
    Date Received
    December 21, 2010
    Decision Date
    May 10, 2011
    Product Code
    KMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KMJ Lubricant, Patient

    Similar 510(k) Clearances

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

    Lubricating Jelly

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COLONGLIDE LUBRICANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COLONGLIDE(R) LUBRICANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LUBE JELLY SURINGE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DUKAL LUBRICATING JELLY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STERILE LUBRICATING JELLY

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Medline Industries, Inc.

    K Number Device Name
    DEN210049 Medline ART Skin Harvesting System
    K230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
    K223100 Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
    K222665 Medline UNITE® Ankle Fusion Plating System
    K213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
    K212911 Konig Mogen Clamp
    K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser
    K213481 Medline General Surgery Tray
    K212093 Medline Universal Grounding Pad
    K213068 Medline Smoke Evacuation Shroud
    Search all 238 clearances from Medline Industries, Inc. →