BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Microline Surgical, Inc

    Reg #: 1223422 · FEI: 1000137656 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    Microline Surgical, Inc
    Registration Number
    1223422
    FEI Number
    1000137656
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 Dunham Rd
    City
    BEVERLY
    State
    MA
    ZIP
    01915
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981188

    Owner / Operator

    Firm Name
    MICROLINE SURGICAL, INC.
    Operator Number
    9006317
    Address
    50 DUNHAM RD, Suite 1500
    City
    Beverly
    State
    MA
    Postal Code
    01915
    Country
    US

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Clip, Implantable FZP
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Laparoscope, General & Plastic Surgery GCJ
    Laparoscopic Accessories, Gynecologic NWV
    Unit, Cautery, Thermal, Ac-Powered HQO

    Proprietary Names

    ReNew Disposable Scissor Tips ReNew XR Handpiece ReNew XR Handpiece with Reference Length Markings REVEEL Ten Comfort Disposable Scope Warmer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device