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

    STRYKER URETERAL ILLUMINATION SYSTEM IV

    K Number: K061548 · Decision Sep 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    124
    Review Days
    115

    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
    STRYKER URETERAL ILLUMINATION SYSTEM IV
    K Number
    K061548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Corp.
    Date Received
    June 5, 2006
    Decision Date
    September 28, 2006
    Product Code
    FCS
    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
    FCS Light, Catheter, Fiberoptic, Glass, Ureteral

    Similar 510(k) Clearances

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

    STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]

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

    STRYKER URETERAL ILLUMINATOR SYSTEM III

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

    URIGLOW TRANSILLUMINATING URETERIC STENT MODEL

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

    GABRIEL URETERAL ILLUMINATOR SYSTEM II

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

    URETERAL ILLUMINATOR

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

    GABRIEL URETERAL ILLUMINATOR SYSTEM

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

    Other Clearances by Stryker Corp.

    K Number Device Name
    K230045 HipCheck
    K191259 Stryker CrossFlow Integrated Arthroscopy Pump
    K182359 HipCheck
    K143399 Stryker Footed Attachments and Cutting Accessories
    K143320 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
    K150449 LITe Plate System
    K142381 Xia 3 Spinal System
    K133671 ICONIX ALL SUTURE ANCHORS
    K122113 MEMORY METAL STAPLES, EASYCLIP
    K122284 HOFFMANN 3
    Search all 124 clearances from Stryker Corp. →