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

    Intera Refill Kit

    K Number: K213823 · Decision Mar 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    98

    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
    Intera Refill Kit
    K Number
    K213823
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intera Oncology, Inc.
    Date Received
    December 8, 2021
    Decision Date
    March 16, 2022
    Product Code
    PTI
    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
    PTI Non-Coring (Huber) Needle

    Similar 510(k) Clearances

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

    K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Promisemed Safety Huber Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Promisemed Safety Huber Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Promisemed Safety Huber Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

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

    Other Clearances by Intera Oncology, Inc.

    K Number Device Name
    K211121 Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit