AOMORI OLYMPUS CO., LTD. Kuroishi Site

FDA Device Registration & Listing · KUROISHI-SHI Aomori, JP · Registration 9614641

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
9614641
FEI Number
3003995201
Entity Name
AOMORI OLYMPUS CO., LTD. Kuroishi Site
City/State/Country
KUROISHI-SHI Aomori, JP
Establishment Address
2-248-1 OKKONOKI, KUROISHI-SHI Aomori 036-0357, JP
Establishment Type(s)
Manufacture 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
K192498
PMA Number
N/A

All Registered 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 FB-221D FB-241D CLV-190 FB-231D 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 MAJ-1869 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 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 FG-52D FG-54D NA-201SX-4022 NA-201SX-4021 MH-969 MAJ-3 MAJ-1057 KD-VC412Q-0215 FG-226C FG-220P FG-232L FG-804L FG-214P 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 FD-412LR FD-411UR 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 D-201-12704 D-201-10704 GIF-XP170N GIF-1TH190 GIF-H170 D-201-11804 D-201-15004 NM-221C-0427

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2015-04-13
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2025-05-08
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-04-27
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2008-06-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2012-02-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-02-13
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2012-02-13
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-10-30
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2009-03-19
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-06-17
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2026-02-03
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
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2017-12-11
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2017-12-11
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-06-17
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2022-08-25
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
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2026-06-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2006-12-01
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-06-17
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
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-11-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2006-01-31
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-03-28
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-06-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-03-08
QGE Biliary Stent, Drain, And Dilator Accessories Gastroenterology, Urology Class 1 876.5012 2023-11-16
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2016-02-22
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2026-06-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2025-11-17
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 2016-03-29
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2018-08-17
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2021-08-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-08-18
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2008-06-17
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-05-08
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-05-08
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-06-17
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2006-12-01
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2013-06-25
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2025-12-16
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
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-06-13
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2017-12-19
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2010-02-23
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2024-06-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-11-26
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2017-11-26
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2024-06-07
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2008-03-03
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2019-06-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-02-28
QEC Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree Gastroenterology, Urology Class 2 876.4300 2019-06-17
LQC Lithotriptor, Biliary Mechanical Gastroenterology, Urology Class 2 876.4500 2019-12-05
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2025-04-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-06-16
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2006-12-01
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2016-04-26
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-12-20
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2008-06-16
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-11-17
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2025-05-08
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2025-05-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-06-17
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2008-06-17
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-06-12
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2006-12-01
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2013-05-22
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2016-11-16
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2026-03-10
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 2008-06-16
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2025-06-10
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2016-05-17
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-07-29
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-04-30

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
K172288 Wilson-Cook Medical Inc./Cook Endoscopy Fusion OMNI Sphincterotome 2018-04-17
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K240075 FUJIFILM Healthcare Americas Corporation FUJIFILM Endoscope Model EB-710XT 2024-02-07
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18

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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
Z-0013-2023 Hobbs Medical, Inc. 2
Hobbs Medical Cytology Brush Catalog Number: 4204
Z-0014-2023 Hobbs Medical, Inc. 2
Hobbs Medical Cytology Brush Catalog Number: 4206

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614641. Last updated year: 2026. Please use registration number 9614641 when referencing this establishment in official correspondence.
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