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

    ENFit Disposable Enteral Syringe

    K Number: K203410 · Decision Jun 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    6
    Review Days
    221

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    Basic Information

    Device Name
    ENFit Disposable Enteral Syringe
    K Number
    K203410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shantou Wealy Medical Instrument Co.,Ltd
    Date Received
    November 19, 2020
    Decision Date
    June 28, 2021
    Product Code
    PNR
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNR Enteral Syringes With Enteral Specific Connectors

    Similar 510(k) Clearances

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

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    ENFit enteral syringes (NUTRIFIT)

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    Other Clearances by Shantou Wealy Medical Instrument Co.,Ltd

    K Number Device Name
    K222452 Disposable Automatically Retractable Safety Syringes (with detachable needle)
    K210216 Disposable Automatically Retractable Insulin Safety Syringe
    K203613 ENFit Reusable Enteral Syringe
    K141640 AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
    K113587 AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)