BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor

    Reg #: 3009956343 · FEI: 3009956343 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SUTURE EASE, INC.
    Registration Number
    3009956343
    FEI Number
    3009956343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    908 C Street, Suite F-1
    City
    Galt
    State
    CA
    ZIP
    95632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172666

    Owner / Operator

    Firm Name
    Suture Ease, Inc
    Operator Number
    10042219
    Address
    908 C Street, Suite F-1
    City
    Galt
    State
    CA
    Postal Code
    95632
    Country
    US
    Correspondent
    Gena Parker

    Products

    Device Name Product Code
    Instrument, Ligature Passing And Knot Tying HCF
    Endoscopic Tissue Approximation Device OCW

    Proprietary Names

    CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor CrossBow Reusable Passer

    Establishment Types

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