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

    C-FLEX PENROSE DRAINAGE TUBE

    K Number: K833061 · Decision Nov 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    83
    Review Days
    59

    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
    C-FLEX PENROSE DRAINAGE TUBE
    K Number
    K833061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Concept, Inc.
    Date Received
    September 9, 1983
    Decision Date
    November 7, 1983
    Product Code
    FFA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFA Tube, Drainage, Suprapubic

    Similar 510(k) Clearances

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

    CATHETERS, BILIARY CATHETERS, UROLOGICAL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SUCTION TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Concept, Inc.

    K Number Device Name
    K912640 CONCEPT ENDOSTEAL FIXATION DEVICE
    K912957 CONCEPT MICROMILL
    K896648 CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
    K894929 STAPLE FIXATION SYSTEM
    K892376 INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
    K891109 PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
    K881954 CONCEPT POWER SYSTEM
    K884255 CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
    K882121 C-FLO SUCTION TUBE
    K880414 TENDON HARVESTER
    Search all 83 clearances from Concept, Inc. →