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

    OVER THE WIRE STONE BASKET

    K Number: K915538 · Decision Mar 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    37
    Applicant Total
    18
    Review Days
    101

    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
    OVER THE WIRE STONE BASKET
    K Number
    K915538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Dynamics, Inc.
    Date Received
    December 10, 1991
    Decision Date
    March 20, 1992
    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 Medical Dynamics, Inc.

    K Number Device Name
    K974542 TRUE VISION, TRUE VISION II
    K921294 VIDEO ENDOSCOPE-RIGID MODIFICATION
    K934682 SURGICAL VIDEO CAMERA AND ACCESSORIES
    K930568 ADAIR/VERESS NEEDLE INTRODUCER SET
    K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
    K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
    K911296 OPTICAL CATHETER ARTHROSCOPE
    K903339 VIDEO ENDOSCOPE, RIGID
    K904609 XENON LIGHT SOURCE
    K904113 OPERATIVE RECORDING CAMERA
    Search all 18 clearances from Medical Dynamics, Inc. →