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

    SPIRUS MEDICAL SURGICAL INSTRUMENT

    K Number: K080042 · Decision Apr 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    5
    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
    SPIRUS MEDICAL SURGICAL INSTRUMENT
    K Number
    K080042
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spirus Medical, Inc.
    Date Received
    January 8, 2008
    Decision Date
    April 3, 2008
    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 Spirus Medical, Inc.

    K Number Device Name
    K080050 SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
    K062805 MODIFICATION TO ENDO-EASE
    K060235 ENDO-EASE ENDOSCOPIC OVERTUBE
    K052084 ENDO-EASE ENDOSCOPIC OVERTUBE