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

    KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM

    K Number: K810134 · Decision Feb 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    5
    Review Days
    38

    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
    KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM
    K Number
    K810134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Info-Chem
    Date Received
    January 19, 1981
    Decision Date
    February 26, 1981
    Product Code
    MMK
    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
    MMK Container, Sharps

    Similar 510(k) Clearances

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

    Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Community Containers (Flap and Daisy)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PureWay 1.4 Quart Sharps Collector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

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

    Other Clearances by Info-Chem

    K Number Device Name
    K791574 MODIFIED TEMPA-DOT THERMOMETER
    K772233 THERMOMETER RECAL ADAPTER
    K771080 STEAM STERILIZATION INDICATOR
    K771037 THERMOMETER, SINGLE USE, STRIP, TEMPADOT