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

    TRI-MED INFLATABLE ESOPHAGEAL DILATOR

    K Number: K932015 · Decision Feb 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    39
    Applicant Total
    14
    Review Days
    286

    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
    TRI-MED INFLATABLE ESOPHAGEAL DILATOR
    K Number
    K932015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tri-Med Specialties, Inc.
    Date Received
    April 23, 1993
    Decision Date
    February 3, 1994
    Product Code
    KNQ
    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
    KNQ Dilator, Esophageal

    Similar 510(k) Clearances

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

    CRE FIXED WIRE BALLON DILATION CATHETER

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

    ETHICON ENDO-SURGERYOPTICAL DILATOR

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

    HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON

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

    SMART DILATOR

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

    COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

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

    MAXFORCE TTS SINGLE-USE BALLOON DILATOR

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

    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
    K942918 TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
    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
    K932652 TRI-MED PARACENTESIS TRAY
    K931201 TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
    Search all 14 clearances from Tri-Med Specialties, Inc. →