BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Geister K-Rex rongeurs

    K Number: K242759 · Decision Jun 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    267

    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
    Geister K-Rex rongeurs
    K Number
    K242759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geister Medizin Technik GmbH
    Date Received
    September 12, 2024
    Decision Date
    June 6, 2025
    Product Code
    HAE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HAE Rongeur, Manual

    Similar 510(k) Clearances

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

    SQ.line KERRISON

    FDA 510(k)
    FDA Class 2 ·Neurology

    Rebellion, Phantom Multi-Bite Kerrison Rongeur

    FDA 510(k)
    FDA Class 2 ·Neurology

    Rebellion; Phantom Multi-Bite Kerrison Rongeur

    FDA 510(k)
    FDA Class 2 ·Neurology

    KLS Martin Neuro Rongeurs

    FDA 510(k)
    FDA Class 2 ·Neurology

    Rebellion, Phantom Multi-Bite Kerrison Rongeur

    FDA 510(k)
    FDA Class 2 ·Neurology

    Wiggins Medical Surgical Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Geister Medizin Technik GmbH

    K Number Device Name
    K180610 Geister retractor for neuro - and spine surgery
    K022823 VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
    K030788 KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
    K982365 ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
    K933699 GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS