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

    PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER

    K Number: K943836 · Decision Nov 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    33
    Review Days
    108

    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
    PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
    K Number
    K943836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Life Systems, Inc.
    Date Received
    August 5, 1994
    Decision Date
    November 21, 1994
    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 Orion Life Systems, Inc.

    K Number Device Name
    K943835 PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
    K943834 STERILE .9% SODIUM CHLORIDE SOLUTION
    K943830 PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
    K943831 PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
    K943832 STERILE .9% SODIUM CHLORIDE FOR IRRATION
    K943829 PRE-FILLED SYSRINGE W/STERILE WATER
    K943828 STERILE WATER FOR IRRIGATION
    K943833 STERILE WATER FOR IRRATION
    K923168 DUAL PORT ENTERAL Y-ADAPTOR
    K923497 FLUSHING IRRIGATION SET
    Search all 33 clearances from Orion Life Systems, Inc. →