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

    SAF-T-SYRINGE- 0.5 AND 1ML/CC

    K Number: K063340 · Decision Mar 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    120

    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
    SAF-T-SYRINGE- 0.5 AND 1ML/CC
    K Number
    K063340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Safety Medical International, Incorporated
    Date Received
    November 6, 2006
    Decision Date
    March 6, 2007
    Product Code
    MEG
    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
    MEG Syringe, Antistick

    Similar 510(k) Clearances

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

    PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VaporShield

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SaviSafe Safety Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Shina Syringe; Shina Safety Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Safety Insulin and TB Syringes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)

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

    Other Clearances by Safety Medical International, Incorporated

    K Number Device Name
    K051762 SAF-T-SYRINGE/SAF-T-NEEDLE