BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    AOMORI OLYMPUS CO., LTD. Kuroishi Site

    Reg #: 9614641 · FEI: 3003995201 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    343
    Establishment Types
    4
    Classifications
    34

    Registration Details

    Registration Name
    AOMORI OLYMPUS CO., LTD. Kuroishi Site
    Registration Number
    9614641
    FEI Number
    3003995201
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-248-1 OKKONOKI
    City
    KUROISHI-SHI Aomori
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K141991

    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
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Bronchoscope Accessory KTI
    Bronchoscope (Flexible Or Rigid) EOQ
    Instrument, Ultrasonic Surgical LFL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Hemostatic Metal Clip For The Gi Tract PKL
    Endoscopic Cytology Brush FDX
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Gastroscope And Accessories, Flexible/Rigid FDS
    Snare, Flexible FDI
    Snare, Non-Electrical FGX
    Biopsy Needle FCG
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Forceps, Biopsy, Electric KGE
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Colonoscope And Accessories, Flexible/Rigid FDF
    Laparoscope, General & Plastic Surgery GCJ
    Biliary Stent, Drain, And Dilator Accessories QGE
    Needle, Aspiration And Injection, Disposable GAA
    Electrode, Electrosurgical, Active, Urological FAS
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Ligator, Esophageal MND
    Dislodger, Stone, Biliary LQR
    Accessories, Cleaning Brushes, For Endoscope MNL
    Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree QEC
    Lithotriptor, Biliary Mechanical LQC
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Forceps, Biopsy, Non-Electric FCL
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    KD-VC611Q-07303A KD-VC611Q-07203S KD-VC411Q-0730 KD-VC611Q-07203A KD-VC611Q-07201S KD-VC611Q-07301S KD-VC611Q-07301A KD-VC411Q-0720 KD-VC611Q-07201A KD-VC611Q-07303S FG-54D FG-52D FB-456D MAJ-1870 MAJ-1869 ESG-100, AFU-100 MAJ-1873 MAJ-1872 MAJ-1871 MAJ-1876 HX-202UR HX-202LR HX-201LR-135L HX-201UR-135L HX-201LR-135 HX-201UR-135 NM-400L-0523 NM-400U-0425 NM-401L-0423 NM-400U-0423 NM-400Y-0423 NM-400U-0523 NM-400L-0421 MAJ-1352 NA-U401SX-4025N FB-433D MAJ-1538 FD-412LR FD-411UR MAJ-864 NA-U210H-8019 NA-U210H-8025 NA-U210H-8022 MAJ-1214 BC-V600P-3010 CYB-2, CYB-3 MAJ-860 SD-210U-15 FB-211D FB-241D FB-231D FB-221D VirtuoSaph Plus Endoscopic Vein Harvesting System MAJ-1818 MAJ-1819 MAJ-1821 MAJ-1820 NA-411D-1321 NA-601D-1519 NA-401D-1521 NA-401D-1321 NA-411D-1521 SD-230U-20 KD-650L KD-612L KD-650U KD-612U KD-620UR BF-Q170 BF-1TQ170 FB-19SX-1 CLV-190 NM-610L-0623 NM-610U-0423 NM-610L-0621 NM-610U-0323 NM-610U-0426 NM-610U-0425 NM-610L-0421 NM-610U-0523 NM-610L-0426 NM-610U-0623 NM-610L-0525 NM-610U-0326 NM-610L-0625 NM-610L-0423 NM-610L-0425 NM-610U-0525 NM-610L-0523 NM-610U-1826 NM-610L-0521 NM-610U-0625 FG-232L FS-410L FS-200L FG-244NR FS-410U FG-253SX FG-460YR FG-214P FG-804L FG-600U FG-220P SB-0520FC USG-410 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 D-201-11804 D-201-12704 D-201-11802 D-201-11304 D-201-15004 D-201-14304 D-201-10704 KD-V611M-07302S KD-V611M-07202A KD-V611M-07251S KD-V631M-07202S KD-V611M-07251A KD-V631M-07302A KD-V611M-07201S KD-V611M-07252S KD-V611M-07252A KD-V631M-07201A KD-V631M-07201S KD-V611M-07202S KD-V631M-07202A KD-V611M-07302A KD-V611M-07301A KD-V611M-07301S KD-V611M-07201A KD-V631M-07302S KD-V631M-07301S KD-V441M KD-V451M B-V243Q-A B-V433P-B B-V433P-A B-V443Q-B B-V233P-B B-V443Q-A B-V243Q-B B-V233P-A B5-2C KD-655L KD-655U KD-610L KD-640L KD-611L HX-810LR HX-610-135 HX-610-090L HX-610-090 HX-810UR HX-610-090S HX-610-135L HX-610-135XS HX-610-135S USG-400 PBD-1030-1012 PBD-1030-0707 PBD-1030-1009 PBD-1030-0709 PBD-1030-1015 PBD-1030-0715 PBD-1030-0712 PBD-1030-1007 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 FD-231C BML-V232QR-30 BML-610A MAJ-441 BML-V437QR-30 BML-V232QR-26 BML-V237QR-30 BML-V242QR-30 BML-V442QR-30 MAJ-2502 NA-201SX-4022 NA-201SX-4021 MH-969 MAJ-3 MAJ-1057 KD-VC412Q-0215 FG-226C MAJ-1243 MAJ-1534 MAJ-877 B5-2Q B7-2LA B7-2Q FG-V422PR FG-V431P FG-V421PR FG-V432P SD-221U-25 NA-U200H-8025 NA-U200H-8019 NA-U200H-8019S NA-U200H-8022S NA-U200H-8022 NA-U401SX-4021 NA-U401SX-4022 FD-410LR BC-205D-2010 PBD-230-0706 PBD-230-0702 PBD-230-0708 PBD-234-0706 PBD-234-0712 PBD-230-0704 PBD-234-0708 PBD-234-0710 PBD-234-1008 PBD-234-1006 PR-V427Q PR-V414Q PR-V614M PR-V418Q PR-V435Q PR-V416Q PR-V223Q PR-V420Q PR-V434Q BD-210N-0620 BD-210N-0830 BD-210N-0440 BD-210N-0640 BD-210N-0420 GIF-XP170N GIF-1TH190 GIF-H170 NM-221C-0427 SD-210U-25 SD-210U-10 TD-410 MAJ-2467 TB2-0535FC TB2-0520FC TB2-0545FC TB2-0525FC FG-45U-1 SD-240U-15 SD-240U-10 MAJ-22 MAJ-525 MAJ-1414 HX-400U-30 KD-V411M-0320 KD-V411M-0330 KD-V411M-0720 KD-V411M-0725 BC-203D-2006 BC-202D-5010 BC-202D-1210 BC-202D-3010 BC-202D-2010 FG-V451P K-401 K-402 CC-220DR KD-VC433Q-0720 KD-VC411Q-0320 KD-VC631Q-07203A KD-VC631Q-07303A KD-VC431Q-0720 KD-411Q-0730 KD-VC631Q-07301S KD-VC631Q-07303S KD-VC631Q-07201S KD-VC631Q-07203S KD-VC433Q-0730 KD-VC411Q-0330 KD-V431M-0720 KD-V411M-0730 KD-431Q-0720 KD-VC631Q-07201A KD-VC631Q-07301A KD-VC431Q-0730 KD-V431M-0730 NA-U201H-8019 NA-U201H-8025 NA-U201H-8022 BD-VC431Q-1240-30 BD-VC431Q-1240-25 BD-VC431Q-1240-20 FB-225U FB-215U FB-245U FB-210K FB-221K FB-242U FB-230K FB-210U FB-214U FB-235U FB-224U FB-222U FB-41ST-1 FB-211K FB-240K FB-234U FB-244U FB-50U-1 FB-240U FB-231K FB-241K FB-220K FB-230U FLEXIBLE BIOPSY FORCEP FB-212U FB-232U FB-220U FB-26N-1 BD-VC431Q-1840-30 BD-VC431Q-1840-25 BD-VC431Q-1840-20 KD-625LR KD-645L KD-625UR

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device