BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Uroplasty, LLC

    Reg #: 3002647932 · FEI: 3002647932 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    7
    Establishment Types
    4
    Classifications
    8

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    Registration Details

    Registration Name
    Uroplasty, LLC
    Registration Number
    3002647932
    FEI Number
    3002647932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5420 FELTL ROAD
    City
    Minnetonka
    State
    MN
    ZIP
    55343
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121337
    PMA Number
    P040050

    Owner / Operator

    Firm Name
    Uroplasty, LLC
    Operator Number
    9077485
    Address
    5420 FELTL RD., --
    City
    Minnetonka
    State
    MN
    Postal Code
    55343
    Country
    US
    Correspondent
    Nicole Boser

    Products

    Device Name Product Code
    System, Vocal Cord Medialization MIX
    Agent, Bulking, Injectable For Gastro-Urology Use LNM
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Needle, Gastro-Urology FHR
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Catheter, Balloon, Urethral, Drug-Coated QRH
    Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence NAM
    Dilator, Urethral KOE

    Proprietary Names

    VOX Implants MACROPLASTIQUE IMPLANTS Rigid Endoscopic Needle Administration Device Optilume® Urethral Drug Coated Balloon Kit Urgent PC Neuromodulation System Optilume Basic Urological Balloon Dilation Catheter with Basic Balloon Kit

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device