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

    STONE EXTRACTOR

    K Number: K971123 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    73
    Applicant Total
    49
    Review Days
    92

    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
    STONE EXTRACTOR
    K Number
    K971123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phx Technologies Corp.
    Date Received
    March 27, 1997
    Decision Date
    June 27, 1997
    Product Code
    OCZ
    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
    OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

    Similar 510(k) Clearances

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

    KARL STORZ Endoscopic Accessories for Urology

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

    SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

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

    Single Use Grasping Forceps

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

    Grasping Forceps

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

    Ensizor Endoscopic Scissors

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

    ENSIZOR ENDOSCOPIC SCISSORS

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

    Other Clearances by Phx Technologies Corp.

    K Number Device Name
    K974327 WINGED NEEDLE HOLDER
    K954508 RETRACTOR
    K954509 PROBE KNIFE
    K954507 RETROGRADE KNIFE
    K954510 RRIANGLE KNIFE
    K954459 CONICAL OBTURATOR
    K954475 BLUNT DISSECTOR, CURVED
    K954464 CARPAL TUNNEL SLOTTED CANNULA
    K954458 BOAT NOSE OBTURATOR
    K954463 DISSECTING OBTURATOR
    Search all 49 clearances from Phx Technologies Corp. →