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

    ENDOSCOPIC RETRIEVAL BASKET

    K Number: K922114 · Decision Aug 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    14
    Review Days
    90

    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
    ENDOSCOPIC RETRIEVAL BASKET
    K Number
    K922114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intramed Laboratories, Inc.
    Date Received
    May 5, 1992
    Decision Date
    August 3, 1992
    Product Code
    FFL
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

    Similar 510(k) Clearances

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

    Peralta Stone Removal Catheter

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

    Accordion Piccolo Stone Management Device

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

    ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

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

    COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015

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

    ACCORDION

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

    REPROCESSED STONE RETRIEVAL BASKETS

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

    Other Clearances by Intramed Laboratories, Inc.

    K Number Device Name
    K953258 TITANIUM HEMOSTATIC CLIP
    K942457 GRAFT THROMBECTOMY INSTRUMENTS
    K931792 ARTHROSCOPE
    K925283 VALVULOTOME
    K934696 ANGIOSCOPE
    K914385 OPTICAL VALVULOTOME
    K904465 FLEXIBLE ARTHROSCOPE
    K903528 LAPAROSCOPE
    K902444 CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
    K901010 FLEXIBLE CHOLEDOCHOSCOPE
    Search all 14 clearances from Intramed Laboratories, Inc. →