BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SILCLEAR TUBING

    K Number: K943992 · Decision Mar 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    19
    Review Days
    212

    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
    SILCLEAR TUBING
    K Number
    K943992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Degania Silicone , Ltd.
    Date Received
    August 16, 1994
    Decision Date
    March 16, 1995
    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 Degania Silicone , Ltd.

    K Number Device Name
    K254170 Percutaneous Endoscopic Gastrostomy (PEG) Kit
    K233591 Stylus
    K152246 Aquarius Stoma Measuring Device
    K143378 AQUARIUS Gastrostomy Replacement Tube
    K141753 AQUARIUS NASAL FEEDING TUBE
    K141631 AQUARIUS EXTENSION FEEDING SET
    K132686 AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
    K131020 TEMPERATURE SENSOR CATHETER
    K122030 LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
    K103371 COUDE/ OR TIEMANN
    Search all 19 clearances from Degania Silicone , Ltd. →