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

    Sol-Guard Auto-disable Syringe

    K Number: K220713 · Decision May 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    13
    Review Days
    419

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    Basic Information

    Device Name
    Sol-Guard Auto-disable Syringe
    K Number
    K220713
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sol-Millennium Medical, Inc.
    Date Received
    March 11, 2022
    Decision Date
    May 4, 2023
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Sol-Millennium Medical, Inc.

    K Number Device Name
    K253110 Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
    K250907 Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
    K242291 SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
    K242099 Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
    K241821 Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
    K222744 Sol-M Luer Lock Syringe
    K213718 SOL-GUARD Safety Pull Button Collection Set
    K182146 Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
    K163073 Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
    K162030 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
    Search all 13 clearances from Sol-Millennium Medical, Inc. →