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

    ENDOSOPIC STENE MANIPULATING BALLOON

    K Number: K850489 · Decision Apr 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    37
    Applicant Total
    46
    Review Days
    73

    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
    ENDOSOPIC STENE MANIPULATING BALLOON
    K Number
    K850489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mill-Rose Laboratory
    Date Received
    February 8, 1985
    Decision Date
    April 22, 1985
    Product Code
    LQR
    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
    LQR Dislodger, Stone, Biliary

    Similar 510(k) Clearances

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

    Disposable Stone Extraction Basket

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

    Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P

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

    Extraction Basket

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

    Single-use Extraction Baskets

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

    Stone Extraction Baskets

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

    SpyGlass Discover Retrieval Basket

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

    Other Clearances by Mill-Rose Laboratory

    K Number Device Name
    K983122 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
    K983124 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
    K971275 MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
    K962736 MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
    K960880 MILL-ROSE BLIND MICROBIOLOGY BRUSH
    K954519 WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
    K951600 MILL-ROSE ROTATABLE POLYPECTOMY SNARE
    K954745 MILL-ROSE RIGID SCOPE CLEANING BRUSHES
    K951051 RITE-BITE BIOPSY FORCEPS
    K951048 RITE-BITE BIOPSY FORCEPS
    Search all 46 clearances from Mill-Rose Laboratory →