BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    TK Sterile Piston Syringe without Needle

    K Number: K191642 · Decision Jan 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    12
    Review Days
    201

    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
    TK Sterile Piston Syringe without Needle
    K Number
    K191642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Received
    June 19, 2019
    Decision Date
    January 6, 2020
    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

    Similar 510(k) Clearances

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

    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Instylla Delivery Kit

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

    Other Clearances by Anhui Tiankang Medical Technology Co., Ltd.

    K Number Device Name
    K222772 Oral/Enteral Syringe with ENFit connector
    K222773 Feeding Tube
    K230756 TK Pre-Filled Normal Saline Flush Syringe
    K222385 Bifurcated Needle
    K220204 Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
    K212368 Surgical Face Mask
    K210464 Auto Disable Syringe
    K191639 TK Insulin Syringe with/without Saftey Retractable Device
    K191640 TK Intravascular Administration Set
    K191644 TK Safety Needle
    Search all 12 clearances from Anhui Tiankang Medical Technology Co., Ltd. →