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

    Salem Sump Dual Lumen Stomach Tube with ENFit Connection

    K Number: K190923 · Decision Nov 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    32
    Review Days
    212

    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
    Salem Sump Dual Lumen Stomach Tube with ENFit Connection
    K Number
    K190923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinalhealth
    Date Received
    April 9, 2019
    Decision Date
    November 7, 2019
    Product Code
    PIF
    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
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

    Similar 510(k) Clearances

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

    Percutaneous Endoscopic Gastrostomy (PEG) Kit

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

    Enteral Drainage System, Enteral Medicine straw

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

    Extension Feeding Set with ENFit™ Connectors

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

    Disposable Enteral Feeding Sets

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

    Mobility+ Enteral Feeding System OTC

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

    ENFit to ENFit Extension Sets

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

    Other Clearances by Cardinalhealth

    K Number Device Name
    K252313 Cardinal Health Nitrile Examination Gloves Extended Cuff
    K243660 Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
    K243652 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)
    K230569 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
    K213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
    K202217 Kendall NPWT Incision Management Device
    K191101 Kendall NPWT Incision Management Dressing Kit
    K171499 Occlusion Detection Dressing Kit
    K161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
    K150769 Cardinal Health Trochanteric IM Nail System
    Search all 32 clearances from Cardinalhealth →