BEUDAMED
    Product Code: PTI FDA class 2 21 CFR 880.5570

    Non-Coring (Huber) Needle

    General Hospital

    The Non-Coring (Huber) Needle is a specially designed needle with a deflected tip used to access subcutaneous implanted intravascular infusion ports without coring the port's septum, thereby preserving septum integrity for repeated use; it can also access other non-vascular implanted devices with similar septums. It is classified as FDA Class 2 under 21 CFR 880.5570 in the General Hospital specialty, requiring 510(k) premarket notification. Product code PTI; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    13
    FEI Numbers
    31
    Registration Numbers
    31
    Unique Applicants
    10
    Years Active
    9

    Basic Information

    Product Code
    PTI
    Device Class
    FDA class 2
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 13 510(k) clearances via K numbers.

    K Number Device Name
    K252355 K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
    K251138 Promisemed Safety Huber Needles
    K243332 Promisemed Safety Huber Needles
    K241353 PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set
    K230715 Promisemed Safety Huber Needle
    K213823 Intera Refill Kit
    K211121 Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
    K200463 Huber Needle Infusion Set, Safety Huber Needle Infusion Set
    K170881 ISP Safety Huber Needle Infusion Set
    K170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
    K171735 PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
    K171333 20G x 5/8 Pro-Lock CT Safety Infusion Set
    K162271 Pro-Lock CT Safety Infusion Set

    FEI Numbers

    This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.