BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SHIRAKAWA OLYMPUS CO., LTD.

    Reg #: 3002808148 · FEI: 3002808148 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    268
    Establishment Types
    3
    Classifications
    42

    Registration Details

    Registration Name
    SHIRAKAWA OLYMPUS CO., LTD.
    Registration Number
    3002808148
    FEI Number
    3002808148
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-1 Okamiyama, Odakura, NISHIGO-MURA
    City
    NISHISHIRAKAWA-GUN Fukushima
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K133538

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Bronchoscope (Flexible Or Rigid) EOQ
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    Confocal Optical Imaging OWN
    Endoscopic Irrigation/Suction System OCX
    Transducer, Ultrasonic, Diagnostic ITX
    Led Light Source NTN
    Gastroscope And Accessories, Flexible/Rigid FDS
    Colonoscope And Accessories, Flexible/Rigid FDF
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Camera, Surgical And Accessories KQM
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Laparoscope, Gynecologic (And Accessories) HET
    Laparoscope, General & Plastic Surgery GCJ
    Ultrasound Bronchoscope PSV
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Instrument, Ultrasonic Surgical LFL
    Spatial Imaging For Display Of Endoscope Position PGU
    Enteroscope And Accessories FDA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Accessories, Cleaning Brushes, For Endoscope MNL
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Insufflator, Laparoscopic HIF
    Insufflator, Endoscopic Vessel Harvesting OSV
    Light Source, Endoscope, Xenon Arc GCT
    Endoscopic Central Control Unit ODA
    Device, Hardcopy, Images, Ophthalmic NFI
    Endoscope Channel Accessory ODC
    Endoscope, Rigid GCM
    Laryngostroboscope EQL
    Hysteroscope (And Accessories) HIH
    Gastrointesinal Lesion Software Detection System QNP
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Endoscopic Leak Tester PCV
    Transformer, Endoscope GCW

    Proprietary Names

    CV-180 MAJ-1464 MAJ-1462 MH-966 MH-999E CYF-VHA CYF-5 CYF-VH MAJ-207 CYF-VHR CYF-V2 CYF-V2R MAJ-669 MH-968 CH-S700-XZ-EA OTV-S700 CLL-S700 MAJ-2512 MAJ-902 MAJ-901 MAJ-2437 GIF-1100 CV-1500 CF-HQ1100DL MAJ-920 MH-985 CF-HQ1100DI MAJ-2431 UM-3R UM-G20-29R MAJ-1995 MAJ-1919 MAJ-1413 MAJ-1218 MAJ-210 MAJ-209 MAJ-1934 MAJ-1957 Telescope "IR" CH-S200-XZ-EB CH-S200-XZ-EA OTV-S200 Telescope "ULTRA" CLV-S200-IR CV-190 CLV-190 CF-HQ190I CF-HQ190L MAJ-1817 CF-H190I CF-H190L PCF-PH190I MAJ-215 PCF-H190L PCF-PH190L PCF-H190I MAJ-1933 MH-438 OTV-S500 MAJ-2295 BF-UC190F CH-S400-XZ-EB CH-S400-XZ-EA MAJ-1742 MAJ-1741 UCR MAJ-1085 MAJ-1084 MAJ-1196 MAJ-1878 MAJ-1898 UPD-3 MAJ-1899 MAJ-1907 MAJ-1880 MAJ-1879 MAJ-1938 MAJ-1881 MAJ-1890 CV-170 USG-410 TD-410 MAJ-2467 TB2-0535FC TB2-0520FC TB2-0545FC TB2-0525FC UM-S20-20R UM-S20-17S MAJ-2382 EU-ME3 MAJ-2381 MAJ-2383 MAJ-1720 FTL-DEK-B BW-400V BW-403B MAJ-1339 BW-400B BW-411B BW-412T MAJ-1888 BW-400L Cleaning Accessory FTL-DEK-A Single Use Cleaning Brush MAJ-864 CH-S190-08-LB MAJ-1939 MAJ-1985 MH-244 MAJ-1025 MH-856 MH-946 MAJ-1026 MAJ-419 MD-227 MAJ-1024 MH-948 MH-944 MH-553 MH-974 MAJ-1352 CLV-S45 MAJ-1830 MAJ-1831 MAJ-438 AR-TZ2 MH-984 AR-T12Q SB-0520FC SB-0535FC TD-SB400 SB-0545IC SB-0545FC TD-TB400 TB-0920OE TB-0535FCS TB-0520FCS MAJ-2412 SB-0520IC TB-0545FCS TB-0009OF SB-0535IC TB-0009OFX MAJ-1869 OEV262H MAJ-854 MH-995 MAJ-2268 MAJ-2251 UCES-4 MAJ-2528 MAJ-2316 UHI-3 MAJ-1080 MAJ-1443 MAJ-1444 OEV321UH CLV-S190 LTF-S190-10 OTV-S190 MAJ-1956 MAJ-1959 GF-UCT180 MAJ-350 MAJ-629 UM-3R-3 UM-G20-29R-3 UM-S20-20R-3 CH-S190-XZ-Q MAJ-2363 OTV-SI MAJ-2511 MAJ-2432 MAJ-1912 MAJ-1921 Visera Elite II Endoeye 3D MAJ-2549 MAJ-2551 MAJ-2548 MAJ-2550 MAJ-2547 GF-UE190 OIP-1 UHI-4 MAJ-1948 MAJ-1942 BF-Q170 BF-1TQ170 FB-19SX-1 FB-221D FB-241D FB-231D UWIT-TX UWIT-RX MAJ-2011 MAJ-1945 ENF-V3 ENF-VH ENF-GP2 ENF-VH2 ENF-V4 MB-156 BF-1TH190 BF-Q190 BF-H190 OTV-S7PROH-HD-L08E 3DV-190 MAJ-2053 LTF-190-10-3D MAJ-2054 MAJ-683 TC-E300 WM-DP3 TC-C4 WM-NP3 MAJ-684 TC-L TC-C3 TC-E400 MAJ-1962 MAJ-604 MAJ-1859 MAJ-1875 MAJ-1860 MAJ-1868 MAJ-1929 MAJ-1927 MAJ-1057 ENF-VT3 MAJ-1597 MAJ-1710 MAJ-1715 MAJ-1711 MD-252 OBCU MAJ-1727 MAJ-1805 ST-SB1 MAJ-1726 EU-ME1 OTV-S300 MAJ-1941 MAJ-1951 MAJ-1205 MAJ-2020 MAJ-2009 ALT-Pro MAJ-2052 MH-155 MAJ-1430 CV-150 MAJ-1592 MAJ-1466 MAJ-941 MU-1 MAJ-1391 MAJ-905 MAJ-1981 MB-264 MAJ-960 MH-443 MAJ-879 MB-358 MAJ-1586 MB-155 MAJ-1584

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device