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

    SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP

    K Number: K954116 · Decision Nov 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    109

    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
    SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
    K Number
    K954116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technical Products, Inc.
    Date Received
    July 20, 1995
    Decision Date
    November 6, 1995
    Product Code
    FEW
    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
    FEW Catheter, Malecot

    Similar 510(k) Clearances

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

    UNIVERSA PERCULTANEOUS DRAINAGE CATHETER

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

    BARD MALECOT AND PEZZER DRAINS

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

    MANAN MALECOT BASKET DRAINAGE CATHETER

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

    MANAN MALECOT BASKET DRAINAGE CATHETER

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

    OLYMPIC SMART SCALE CARE CENTER

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

    Other Clearances by Technical Products, Inc.

    K Number Device Name
    K013321 SILICONE TRACHEAL T-TUBES
    K973385 OVAL SHAPES
    K973166 DOW CORNING SILASTIC ELASTOMER Q7-4750
    K971472 SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
    K971613 SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING