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

    KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL

    K Number: K950337 · Decision Aug 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    17
    Applicant Total
    334
    Review Days
    208

    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 STAMMBERGER-SACHSE INTRANASAL-FRILL
    K Number
    K950337
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4140
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    January 27, 1995
    Decision Date
    August 23, 1995
    Product Code
    EQJ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQJ Bur, Ear, Nose And Throat

    Similar 510(k) Clearances

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

    Precision Thin Reciprocating Blade, 0.010in.

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    XPS CURVED BUR

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ESSENTIAL SHAVER SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ACE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TREBAY MICRODEBRIDER SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SOF - ABRASION BUR

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    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. →