BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

    K Number: K192164 · Decision Mar 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    102
    Review Days
    210

    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
    Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
    K Number
    K192164
    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
    Olympus Medical Systems Corp.
    Date Received
    August 9, 2019
    Decision Date
    March 6, 2020
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    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 Olympus Medical Systems Corp.

    K Number Device Name
    K260580 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
    K252341 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
    K251807 Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
    K253646 Single Use Distal Cover MAJ-2315 (MAJ-2315)
    K251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
    K252646 Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
    K250945 Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
    K251867 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
    K250862 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
    K250701 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
    Search all 102 clearances from Olympus Medical Systems Corp. →