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

    TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER

    K Number: K942918 · Decision Feb 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    14
    Review Days
    252

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    Basic Information

    Device Name
    TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
    K Number
    K942918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tri-Med Specialties, Inc.
    Date Received
    June 21, 1994
    Decision Date
    February 28, 1995
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

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    Other Clearances by Tri-Med Specialties, Inc.

    K Number Device Name
    K971615 PATTISON ESOPHAGEAL DILATOR
    K970890 #ES-32 SUCTION CATHETER 32 FR.
    K970982 T-RX RETRIEVAL FORCEPS
    K950574 NEEDLE/CANNULA
    K934348 TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
    K945160 PARACENTESIS NEEDLES/CANNULAS
    K924549 TRI-MED QUICK-STEP(TM) RECTAL TUBE
    K932015 TRI-MED INFLATABLE ESOPHAGEAL DILATOR
    K932652 TRI-MED PARACENTESIS TRAY
    K931201 TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
    Search all 14 clearances from Tri-Med Specialties, Inc. →