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

    IMAGICA MICRO-ENDOSCOPE

    K Number: K921393 · Decision Aug 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    5
    Review Days
    150

    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
    IMAGICA MICRO-ENDOSCOPE
    K Number
    K921393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fiberoptic Medical Products, Inc.
    Date Received
    March 23, 1992
    Decision Date
    August 20, 1992
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SmartClip Delivery Catheter (ADR-1715)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FUJIFILM Ultrasonic Endoscope EB-710US

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Fiberoptic Medical Products, Inc.

    K Number Device Name
    K944686 FIBEROPTIC LARYNGOSCOPE HANDLE
    K933598 ENDOSTAR(TM) STYLET
    K912252 INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
    K883779 WALLABY(TM) BLANKET