BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMARTRELEASE® Endoscopic Soft Tissue Release System

    Reg #: 2020601 · FEI: 2020601 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Registration Number
    2020601
    FEI Number
    2020601
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3590 Grand Forks Blvd
    City
    CHARLOTTESVILLE
    State
    VA
    ZIP
    22911
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223406

    Owner / Operator

    Firm Name
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Operator Number
    9004658
    Address
    3590 GRAND FORKS BOULEVARD, --
    City
    Charlottesville
    State
    VA
    Postal Code
    22911
    Country
    US
    Correspondent
    Glenn Gerstenfeld

    Products

    Device Name Product Code
    Knife, Surgical EMF
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Arthroscope HRX

    Proprietary Names

    SMARTRELEASE® Endoscopic Soft Tissue Release System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device