Aomori Olympus Co., Ltd. Hirosaki Site

FDA Device Registration & Listing · Hirosaki-shi Aomori, JP · Registration 3014769442

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014769442
FEI Number
3014769442
Entity Name
Aomori Olympus Co., Ltd. Hirosaki Site
City/State/Country
Hirosaki-shi Aomori, JP
Establishment Address
1-1-5, Ogi-Machi, Hirosaki-shi Aomori 036-8104, JP
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
OLYMPUS CORPORATION (Owner Number: 9067818)
Owner / Operator Contact Address
2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 NA-U401SX-4025N MH-969 MAJ-3 BD-VC431Q-1240-30 BD-VC431Q-1240-25 BD-VC431Q-1240-20 SD-240U-15 SD-240U-10 SD-230U-20 MAJ-22 KD-612U 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 FD-231C BC-203D-2006 BC-202D-5010 BC-202D-1210 BC-202D-3010 BC-202D-2010 FG-226C FG-220P FG-232L FG-804L FG-214P 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 FD-412LR FD-410LR FD-411UR 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-V411M-0720 KD-VC631Q-07301S KD-VC631Q-07303S KD-V411M-0330 KD-VC631Q-07201S KD-V411M-0725 KD-V411M-0320 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 BC-V600P-3010 FB-456D FD-412LR FD-411UR FB-433D MAJ-1538

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2016-02-22
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2015-04-13
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2025-11-17
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-06-17
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-06-12
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2020-02-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-03-28
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2008-06-16
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2026-02-03
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2006-12-01
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2018-08-17
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-06-17
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-06-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-06-17
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2017-12-19
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-07-29
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2026-03-10
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2026-06-16
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2009-09-10
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2009-09-10
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2022-08-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-06-16
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2008-06-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2020-06-04
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-06-04
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-06-17
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2002-02-20
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2002-02-20
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2022-06-22
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-06-17
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2022-08-24
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-07-29
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-04-30
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-10-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2016-05-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-03-08
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2008-03-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2008-06-16
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-06-16
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-06-16
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2008-06-16
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2019-08-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-11-17
QEC Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree Gastroenterology, Urology Class 2 876.4300 2019-06-17
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2025-09-30
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2019-06-17
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2025-06-16
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-12-20
QGE Biliary Stent, Drain, And Dilator Accessories Gastroenterology, Urology Class 1 876.5012 2023-11-16
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2022-04-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-02-28
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2008-06-17
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2010-02-23
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2008-06-16
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2008-06-17
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2008-06-16
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2020-03-09
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-03-09
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2013-06-25
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-06-17
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2007-11-30
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2006-12-01
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2008-03-03
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2024-06-19
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2025-11-17
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2013-05-22
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2024-06-07
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2025-06-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2008-06-16
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2008-06-16
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2026-01-16
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-04-27
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2006-12-01
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-30
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2026-06-16
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2018-05-14
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2018-05-14
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2009-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

OLYMPUS CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004450998 Gyrus ACMI, Inc. Redmond, WA, US
3007389669 Algram Group Ltd Plymouth Devon, GB
9611174 KEYMED (Medical & Industrial Equipment) Ltd SOUTHEND-ON-SEA Essex, GB
3010590422 QUEST MEDICAL IMAGING Wieringerwerf Noord-Holland, NL
3031983124 ODIN MEDICAL LIMITED London London, City of, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20
K172288 Wilson-Cook Medical Inc./Cook Endoscopy Fusion OMNI Sphincterotome 2018-04-17
K150891 Covidien, LLC( Formerly Beacon Endoscopic Corp.) BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System 2015-05-01
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0029-2012 Olympus America Inc. 2
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014769442. Last updated year: 2026. Please use registration number 3014769442 when referencing this establishment in official correspondence.
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