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

    APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY

    K Number: K873563 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    9
    Review Days
    82

    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
    APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
    K Number
    K873563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Aplicare, Inc.
    Date Received
    September 2, 1987
    Decision Date
    November 23, 1987
    Product Code
    JOL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOL Catheter And Tip, Suction

    Similar 510(k) Clearances

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

    STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Aplicare, Inc.

    K Number Device Name
    K923299 APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
    K895039 STERILE SALINE - FOR SUCTION CATHETER LUBRICATION
    K861557 APLICARE SKIN PROTECTANT PREP PAD
    K861558 APLICARE SKIN PROTECTANT SWABSTICK
    K833183 APLICARE ONE ACETONE ALCOHOL SWABSTICK
    K833185 ACETONE ALCOHOL PREP PAD
    K833182 APLICARE ALCOHOL PREP PAD
    K833184 APLICARE THREE ALCOHOL SWABSTICKS