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

    TUM-E-VAC

    K Number: K962850 · Decision Feb 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    19
    Review Days
    214

    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
    TUM-E-VAC
    K Number
    K962850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethox Corp.
    Date Received
    July 22, 1996
    Decision Date
    February 21, 1997
    Product Code
    KDH
    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
    KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

    Similar 510(k) Clearances

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

    GILTECH PLUS CONNECTING TUBE SET

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

    SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS

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

    COMBIPORT FLUID LAVAGE DEVICE

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

    EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT

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

    FLUSHING IRRIGATION SET

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

    TRI-MED QUICK-STEP GASTRIC LAVAGE KIT

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

    Other Clearances by Ethox Corp.

    K Number Device Name
    K040286 ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
    K031195 CUF-COVER (TM)
    K935633 NO-MES
    K921946 TUM-E-VAC BITE BLOCK
    K885220 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
    K894927 SURGI SQUEEZ
    K883977 SURGI-CUF STERILE/NON-STERILE DISPOSABLE
    K860599 ETHOX LAVAGE TUBE
    K844988 ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
    K841512 ETHOX RELIA-FLO 2001 ENTERAL FEED
    Search all 19 clearances from Ethox Corp. →