BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Aomori Olympus Co., Ltd. Hirosaki Site

    Reg #: 3014769442 · FEI: 3014769442 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    306
    Establishment Types
    3
    Classifications
    35

    Registration Details

    Registration Name
    Aomori Olympus Co., Ltd. Hirosaki Site
    Registration Number
    3014769442
    FEI Number
    3014769442
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-1-5, Ogi-Machi
    City
    Hirosaki-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
    Needle, Aspiration And Injection, Disposable GAA
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Biopsy Needle FCG
    Bronchoscope Accessory KTI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Ligator, Esophageal MND
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Gastroscope And Accessories, Flexible/Rigid FDS
    Forceps, Biopsy, Electric KGE
    Electrode, Electrosurgical, Active, Urological FAS
    Dislodger, Stone, Biliary LQR
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Bronchoscope (Flexible Or Rigid) EOQ
    Snare, Flexible FDI
    Hemostatic Metal Clip For The Gi Tract PKL
    Accessories, Cleaning Brushes, For Endoscope MNL
    Transducer, Ultrasonic, Diagnostic ITX
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree QEC
    Biliary Stent, Drain, And Dilator Accessories QGE
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Endoscopic Cytology Brush FDX
    Forceps, Biopsy, Non-Electric FCL
    Colonoscope And Accessories, Flexible/Rigid FDF
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Lithotriptor, Biliary Mechanical LQC
    Hysteroscope Accessories NWW
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Laparoscope, General & Plastic Surgery GCJ
    Snare, Non-Electrical FGX

    Proprietary Names

    NA-411D-1321 NA-601D-1519 NA-401D-1521 NA-401D-1321 NA-411D-1521 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 KD-650L KD-612L KD-650U KD-612U KD-620UR NA-U200H-8025 NA-U200H-8019 NA-U200H-8019S NA-U200H-8022S NA-U200H-8022 NA-U401SX-4025N MAJ-860 SD-210U-15 NM-400L-0523 NM-400U-0425 NM-401L-0423 NM-400U-0423 NM-400Y-0423 NM-400U-0523 NM-400L-0421 FG-232L FS-410L FS-200L FG-244NR FS-410U FG-253SX FG-460YR FG-214P FG-804L FG-600U FG-220P KD-655L KD-655U D-201-12704 D-201-10704 GIF-XP170N GIF-1TH190 GIF-H170 D-201-11804 D-201-15004 FD-410LR FD-412LR FD-411UR SD-230U-20 B-V243Q-A B-V433P-B B-V433P-A B-V443Q-B B-V233P-B B-V443Q-A B-V243Q-B B-V233P-A MH-969 MAJ-3 BD-VC431Q-1240-30 BD-VC431Q-1240-25 BD-VC431Q-1240-20 SD-240U-15 SD-240U-10 MAJ-22 KD-V411M-0320 KD-V411M-0330 KD-V411M-0720 KD-V411M-0725 KD-V441M HX-400U-30 BF-Q170 BF-1TQ170 FB-19SX-1 FB-221D FB-241D CLV-190 FB-231D NM-221C-0427 HX-202UR HX-202LR HX-201LR-135L HX-201UR-135L HX-201LR-135 HX-201UR-135 BD-210N-0620 BD-210N-0830 BD-210N-0440 BD-210N-0640 BD-210N-0420 VirtuoSaph Plus Endoscopic Vein Harvesting System 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-1352 BC-205D-2010 B5-2Q B7-2LA B7-2Q FD-231C BC-202D-5010 BC-202D-2010 BC-202D-3010 BC-203D-2006 BC-202D-1210 FG-226C MAJ-1818 MAJ-1819 MAJ-1821 MAJ-1820 FG-V431P FG-V422PR FG-V432P FG-45U-1 FG-V421PR KD-610L KD-640L KD-611L SD-221U-25 MAJ-525 CC-220DR 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 BC-V600P-3010 CYB-2, CYB-3 MAJ-1057 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 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 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 PBD-1030-1012 PBD-1030-0707 PBD-1030-1009 PBD-1030-0709 PBD-1030-1015 PBD-1030-0715 PBD-1030-0712 PBD-1030-1007 PR-V427Q PR-V414Q PR-V614M PR-V418Q PR-V435Q PR-V416Q PR-V223Q PR-V420Q PR-V434Q MAJ-864 FB-456D FB-433D MAJ-1538 NA-U210H-8019 NA-U210H-8025 NA-U210H-8022 SD-210U-25 SD-210U-10 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 BML-V232QR-30 BML-610A MAJ-441 BML-V437QR-30 BML-V232QR-26 BML-V237QR-30 BML-V242QR-30 BML-V442QR-30 MAJ-2502 Hysteroscope accessories FG-54D FG-52D Sur-Lock MAJ-1214 KD-V451M KD-625LR KD-645L KD-625UR B5-2C MAJ-1414 BD-VC431Q-1840-30 BD-VC431Q-1840-25 BD-VC431Q-1840-20 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 KD-VC412Q-0215 NA-U201H-8019 NA-U201H-8025 NA-U201H-8022 K-401 K-402 NA-U401SX-4021 NA-U401SX-4022 FG-V451P

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device