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

    TECNOL NASO-GASTRIC TUBE HOLDER

    K Number: K891187 · Decision May 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    12
    Applicant Total
    35
    Review Days
    85

    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
    TECNOL NASO-GASTRIC TUBE HOLDER
    K Number
    K891187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    March 6, 1989
    Decision Date
    May 30, 1989
    Product Code
    BSS
    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
    BSS Tube, Nasogastric

    Similar 510(k) Clearances

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

    TurboSEAL Nasogastric Aspiration Tube

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

    ENTERAL FEEDING TUBE

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

    MOSS TUBES, INC. NASAL TUBE - MARK IV

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

    ASPISAFE GASTRIC TUBE

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

    GASTRIC, CATHETER, IRRIGATION & ASPIRATION

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

    RADIUS ENTERAL FEEDING TUBE

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

    Other Clearances by Tecnol New Jersey Wound Care, Inc.

    K Number Device Name
    K913043 MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
    K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
    K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
    K896193 TECNOL LAZER(TM) SURGICAL MASK
    K894205 TECNOL SILK STRIP
    K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010
    K891178 TECNOL SECURE-ALL TUBE HOLDER
    K884440 TECNOL VARIABLE TENSION BANDAGE
    K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
    K882641 TECNOL CATHETER LEG STRAP
    Search all 35 clearances from Tecnol New Jersey Wound Care, Inc. →