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

    COLONGLIDE LUBRICANT

    K Number: K141028 · Decision Jul 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    93

    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
    COLONGLIDE LUBRICANT
    K Number
    K141028
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pediatric Pharmaceuticals, Inc.
    Date Received
    April 22, 2014
    Decision Date
    July 24, 2014
    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(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

    DYNACOR LUBRICATION GEL

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

    Other Clearances by Pediatric Pharmaceuticals, Inc.

    K Number Device Name
    K131617 COLONGLIDE(R) LUBRICANT