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

    0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch

    K Number: K201286 · Decision Aug 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    89

    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
    0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
    K Number
    K201286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nurse Assist, LLC
    Date Received
    May 14, 2020
    Decision Date
    August 11, 2020
    Product Code
    NGT
    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
    NGT Saline, Vascular Access Flush

    Similar 510(k) Clearances

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

    0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Praxiject™ SP 0.9% NaCl

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Flush Syringe (Prefilled 0.9% normal saline solution)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pre-Filled Normal Saline Flush Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TK Pre-Filled Normal Saline Flush Syringe

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