BEUDAMED
    Product Code: PCU FDA class 2 21 CFR 876.5015

    Pancreatic Stent, Covered, Metallic, Removable

    Gastroenterology, Urology

    The Pancreatic Stent, Covered, Metallic, Removable is a gastrointestinal device used to facilitate transmural endoscopic drainage of pancreatic pseudocysts, collections of fluid that develop as a complication of pancreatitis or pancreatic trauma. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5015, requiring 510(k) premarket notification. As a removable metallic stent, it provides temporary drainage while being retrievable after the cyst has resolved. It is flagged as an implant but is not life-sustaining.

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    510(k)s
    11
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    4
    Years Active
    12

    Basic Information

    Product Code
    PCU
    Device Class
    FDA class 2
    Regulation Number
    876.5015
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    To facilitate transmural endoscopic drainage of pancreatic pseudocysts

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K252648 Niti-S SPAXUS Stent
    K220112 AXIOS Stent and Electrocautery-Enhanced Delivery System
    K203132 AXIOS Stent and Electrocautery Enhanced Delivery System
    K192043 AXIOS Stent and Electrocautery Enhanced Delivery System
    K181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
    K163272 AXIOS Stent and Electrocautery Enhanced Delivery System
    K153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
    K152572 AXIOS Stent and Delivery System
    K150692 AXIOS Stent with Electrocautery Enhanced Delivery System
    K140561 AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
    DEN130007 AXIOS STENT AND DELIVERY SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.