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

    AXIOS Stent and Electrocautery-Enhanced Delivery System

    K Number: K220112 · Decision Sep 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    10
    Applicant Total
    231
    Review Days
    237

    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
    AXIOS Stent and Electrocautery-Enhanced Delivery System
    K Number
    K220112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5015
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    January 13, 2022
    Decision Date
    September 7, 2022
    Product Code
    PCU
    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
    PCU Pancreatic Stent, Covered, Metallic, Removable

    Similar 510(k) Clearances

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

    Niti-S SPAXUS Stent

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

    AXIOS Stent and Electrocautery Enhanced Delivery System

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

    AXIOS Stent and Electrocautery Enhanced Delivery System

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

    AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

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

    AXIOS Stent and Electrocautery Enhanced Delivery System

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

    AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

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

    Other Clearances by Boston Scientific Corporation

    K Number Device Name
    K260428 RIVOS™ EUS Access Device (M00553900)
    K260100 MOSES Raydar™
    K260771 TruSelect™ 2.6 Microcatheter
    K251273 Asurys Fluid Management System
    K260479 TheraSphere 360™ Y-90 Management Platform
    K260119 SpaceOAR Vue System (SV-2101)
    K252529 Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)
    K253376 OBSIDIO™ Conformable Embolic (M0013972101010)
    K252547 TheraSphere 360™ Y-90 Management Platform
    K252921 Radial Jaw 4 Pulmonary Biopsy Forceps
    Search all 231 clearances from Boston Scientific Corporation →