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

    Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)

    K Number: K162188 · Decision Sep 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    49

    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
    Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
    K Number
    K162188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vr Medical Technology
    Date Received
    August 4, 2016
    Decision Date
    September 22, 2016
    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.

    Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Profoject™ Enteral Feeding Syringe

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Nutricair Enteral Syringe with ENFit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oral/Enteral Syringe with ENFit connector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENFit enteral syringes (NUTRIFIT)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all