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

    STERILE WATER SOLUTION CATALOG # 10000

    K Number: K904216 · Decision Nov 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    14
    Review Days
    65

    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
    STERILE WATER SOLUTION CATALOG # 10000
    K Number
    K904216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Superior Healthcare Group, Inc.
    Date Received
    September 12, 1990
    Decision Date
    November 16, 1990
    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 Superior Healthcare Group, Inc.

    K Number Device Name
    K925530 INSTRUMENT WARMER
    K924764 OVERTUBE FOR ENDSCOPIC LIGATOR
    K905755 NON-STERILE PATIENT EXAMINATION GLOVES
    K903347 SODIUM CHLORIDE SOLUTION
    K903340 STERILE URETHRAL CATHETER PROCEDURE KITS
    K896321 NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
    K894676 STERILE LATEX EXAM GLOVES
    K891445 LATEX EXAMINATION GLOVES
    K892426 NO. 86500 - ENDOSCOPIC JET WASHER
    K885339 FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
    Search all 14 clearances from Superior Healthcare Group, Inc. →