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

    MEDICAL GRADE SILICONE ELASTOMER TUBING

    K Number: K781087 · Decision Nov 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    14
    Review Days
    146

    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
    MEDICAL GRADE SILICONE ELASTOMER TUBING
    K Number
    K781087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mcghan Medical Corp.
    Date Received
    June 29, 1978
    Decision Date
    November 22, 1978
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

    Similar 510(k) Clearances

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

    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMPOWER TRANSFER SET, (CAT. NO. 7725)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDRAD SWABBABLE VALVE TRANSFER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Mcghan Medical Corp.

    K Number Device Name
    K873476 MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS
    K873475 MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS
    K870754 MCGHAN TISSUE EXPANDER FILL SYSTEM
    K864184 MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN
    K864185 MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN
    K862203 MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER
    K854794 MCGHAN INTEGRAL VALVE TISSUE EXPANDER
    K853014 MCGHAN TISSUE EXPANDER FILL KIT
    K843704 MCGHAN TISSUE EXPANDER
    K781700 IONOTPHORETIC APPLICATOR
    Search all 14 clearances from Mcghan Medical Corp. →