BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KARL STORZ DRILL

    K Number: K952008 · Decision Jul 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    40
    Applicant Total
    334
    Review Days
    89

    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
    KARL STORZ DRILL
    K Number
    K952008
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    April 28, 1995
    Decision Date
    July 26, 1995
    Product Code
    GEY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEY Motor, Surgical Instrument, Ac-Powered

    Similar 510(k) Clearances

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

    ADVANCED TURBO DRIVE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SYMPHONY GRAFT DELIVERY SYSTEM (GDS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MEDNEXT 1000 DRILL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AQUA SPRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BONE AND MARROW COLLECTION SYSTEM KIT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
    K252624 KARL STORZ Laryngoscopes and Accessories
    K223923 HOPKINS Telescopes
    K202957 Flexible Video Cysto-Urethroscope (C-view)
    K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
    K182723 Flexible HD Cysto-Urethroscope System
    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
    Search all 334 clearances from KARL STORZ Endoscopy-America, Inc. →