FDA Registration Active 🇯🇵 Japan

OLYMPUS MEDICAL SYSTEMS CORP.

Reg #: 8010047 · FEI: 3002807795 · Expires 2026
Products
74
Proprietary Names
710
Establishment Types
2
Classifications
74

Registration Details

Registration Name
OLYMPUS MEDICAL SYSTEMS CORP.
Registration Number
8010047
FEI Number
3002807795
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2951 ISHIKAWA-CHO
City
HACHIOJI-SHI Tokyo
Country
JP

Regulatory Submissions

510(k) Number
K140008

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
Phone
508 2077661

Products

Device Name Product Code
Electrosurgical, Cutting & Coagulation & Accessories GEI
Bronchoscope (Flexible Or Rigid) EOQ
System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
Endoscopic Central Control Unit ODA
Laparoscope, General & Plastic Surgery GCJ
Endoscopic Irrigation/Suction System OCX
Microscope, Surgical EPT
Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
Gastroscope And Accessories, Flexible/Rigid FDS
Accessories, Cleaning, For Endoscope FEB
System, Imaging, Pulsed Doppler, Ultrasonic IYN
Ultrasound Bronchoscope PSV
Transducer, Ultrasonic, Diagnostic ITX
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Endoscope, Accessories, Narrow Band Spectrum NWB
Endoscopic Ultrasound System, Gastroenterology-Urology ODG
Forceps, Biopsy, Electric KGE
Stents, Drains And Dilators For The Biliary Ducts FGE
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Laparoscope, Gynecologic (And Accessories) HET
Confocal Optical Imaging OWN
Biopsy Needle FCG
Snare, Flexible FDI
Electrode, Electrosurgical, Active, Urological FAS
Colonoscope And Accessories, Flexible/Rigid FDF
Endoscope Channel Accessory ODC
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
Bronchoscope Accessory KTI
Insufflator, Laparoscopic HIF
Duodenoscope And Accessories, Flexible/Rigid FDT
Dislodger, Stone, Biliary LQR
Nasopharyngoscope (Flexible Or Rigid) EOB
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree QEC
Device, Hardcopy, Images, Ophthalmic NFI
Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
Gastrointesinal Lesion Software Detection System QNP
Ligator, Esophageal MND
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Led Light Source NTN
Choledochoscope And Accessories, Flexible/Rigid FBN
Instrument, Ultrasonic Surgical LFL
Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
Needle, Aspiration And Injection, Disposable GAA
Insufflator, Endoscopic Vessel Harvesting OSV
Forceps, Biopsy, Non-Electric FCL
Hysteroscope (And Accessories) HIH
Spatial Imaging For Display Of Endoscope Position PGU
Enteroscope And Accessories FDA
Endoscopic Access Overtube, Gastroenterology-Urology FED
Hemostatic Metal Clip For The Gi Tract PKL
Cystoscope And Accessories, Flexible/Rigid FAJ
Source, Carrier, Fiberoptic Light EQH
Biliary Stent, Drain, And Dilator Accessories QGE
System, Imaging, Pulsed Echo, Ultrasonic IYO
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
Ureteroscope And Accessories, Flexible/Rigid FGB
Endoscopic Cytology Brush FDX
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Accessories, Cleaning Brushes, For Endoscope MNL
Endoscopic Bite Block MNK
Endoscopic Guidewire, Gastroenterology-Urology OCY
Hysteroscope Accessories NWW
Cystourethroscope FBO
System, X-Ray, Angiographic IZI
Lithotriptor, Biliary Mechanical LQC
Light Source, Endoscope, Xenon Arc GCT
Camera, Surgical And Accessories KQM
Dislodger, Stone, Basket, Ureteral, Metal FFL
Transformer, Endoscope GCW
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Endoscope, Rigid GCM
Snare, Non-Electrical FGX
Endoscopic Leak Tester PCV
Laryngostroboscope EQL

Proprietary Names

VirtuoSaph Plus Endoscopic Vein Harvesting System MAJ-2268 MAJ-2251 UCES-4 MAJ-2528 MAJ-1555 MAJ-2305 UCR SD-221U-25 MAJ-2295 BF-UC190F MAJ-1838 MAJ-1837 OER-MINI MAJ-1937 MAJ-1836 MAJ-1904 MAJ-1511 MAJ-1514 MAJ-1513 MAJ-1515 MAJ-1516 OTV-S700 MAJ-2511 CH-S700-XZ-EA CLL-S700 CH-S400-XZ-EB CH-S400-XZ-EA FD-412LR FD-410LR FD-411UR SD-210U-15 SD-210U-25 SD-210U-10 CH-S190-XZ-Q MAJ-2363 OTV-SI CV-1500 MAJ-2432 OTV-S200 MAJ-2512 CH-S190-08-LB BD-VC431Q-1240-30 BD-VC431Q-1240-25 BD-VC431Q-1240-20 Telescope "IR" CH-S200-XZ-EB CH-S200-XZ-EA Telescope "ULTRA" CLV-S200-IR MAJ-1414 SD-240U-15 SD-240U-10 SD-230U-20 MAJ-22 AR-TZ2 MH-999E MH-984 AR-T12Q KD-625LR KD-645L KD-625UR MAJ-1957 MAJ-1934 MH-966 GIF-EZ1500 CF-EZ1500DL CF-EZ1500DI MAJ-1443 MAJ-1444 FG-232L FS-410L FS-200L FG-244NR FS-410U FG-253SX FG-460YR FG-214P FG-804L FG-600U FG-220P KD-610L KD-640L KD-611L FG-52D FG-54D NA-201SX-4022 NA-201SX-4021 UHI-3 MAJ-1080 MAJ-1084 MAJ-1085 B-V243Q-A B-V433P-B B-V433P-A B-V443Q-B B-V233P-B B-V443Q-A B-V243Q-B B-V233P-A ENF-VT3 MAJ-855 UWIT-TX UWIT-RX MAJ-2011 MAJ-1945 FD-231C MAJ-1597 MAJ-1352 MAJ-854 MH-995 BC-202D-5010 BC-202D-2010 BC-202D-3010 BC-203D-2006 OIP-1 HX-400U-30 MAJ-683 TC-E300 WM-DP3 TC-C4 WM-NP3 MAJ-684 TC-L TC-C3 TC-E400 OTV-S500 MA-238 NA-411D-1321 NA-601D-1519 NA-401D-1521 NA-401D-1321 NA-411D-1521 ENF-VH ENF-V3 MAJ-860 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 UM-3R UM-G20-29R MH-438 UHI-4 BC-205D-2010 OTV-S300 MAJ-1941 MAJ-1951 MAJ-1205 FB-211D 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 MAJ-1870 MAJ-1869 ESG-100, AFU-100 MAJ-1873 MAJ-1872 MAJ-1871 MAJ-1876 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 NA-U200H-8025 NA-U200H-8019 NA-U200H-8019S NA-U200H-8022S NA-U200H-8022 MAJ-1057 B5-2Q B7-2LA B7-2Q D-201-11804 D-201-12704 D-201-11802 D-201-11304 D-201-15004 D-201-14304 D-201-10704 ENF-GP2 MAJ-1878 MAJ-1898 UPD-3 MAJ-1899 MAJ-1907 MAJ-1880 MAJ-1879 MAJ-1938 MAJ-1881 MAJ-1890 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 OTV-S7PROH-HD-L08E MD-493 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 MAJ-1948 MAJ-1942 CYF-VHR CYF-V2 CYF-V2R CYF-VH MAJ-900 Light carrier, fiber optic Throat microphone Light Source MAJ-1818 MAJ-1819 MAJ-1821 MAJ-1820 MAJ-1710 MAJ-1715 MAJ-1711 MD-252 EU-ME1 EU-ME3 GF-UCT180 MAJ-1720 KD-655L KD-655U BF-1TH190 BF-Q190 BF-H190 CV-190 3DV-190 MAJ-2053 LTF-190-10-3D MAJ-2054 CV-180 MAJ-1464 MAJ-1462 MAJ-2382 MAJ-2381 MAJ-2383 MAJ-1995 FD-230U FD-210U PBD-1030-1012 PBD-1030-0707 PBD-1030-1009 PBD-1030-0709 PBD-1030-1015 PBD-1030-0715 PBD-1030-0712 PBD-1030-1007 MAJ-1830 MAJ-1831 MAJ-438 GIF-XP170N GIF-1TH190 GIF-H170 MAJ-2437 GIF-1100 CF-HQ1100DL MAJ-920 MH-985 CF-HQ1100DI MAJ-2431 B5-2C FG-226C 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 FG-V431P FG-V422PR FG-V432P FG-45U-1 FG-V421PR HX-202UR HX-202LR HX-201LR-135L HX-201UR-135L HX-201LR-135 HX-201UR-135 CC-220DR TJF-Q190V NA-U210H-8019 NA-U210H-8025 NA-U210H-8022 MAJ-1970 MAJ-1545 MAJ-1508 MAJ-1498 MAJ-2131 MAJ-1504 MAJ-1969 MAJ-1517 MAJ-2124 MAJ-1512 MAJ-1505 MAJ-1764 MAJ-1971 MAJ-1503 MAJ-1546 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 TJF-Q170V TD-410 MAJ-2467 TB2-0535FC TB2-0520FC TB2-0545FC TB2-0525FC MAJ-2092 OTV-SP1H-NA-12E OTV-S7H-1NA-12Q OTV-S7H-1NA-10E OTV-S7H-VA OTV-S7PROH-HD-12Q OTV-S7H-N OTV-S7H-1NA-12E LTF-S190-5 OTV-S7H-NA-12E OTV-S7H-1NA OTV-S7H-NA NA-U401SX-4025N MAJ-2138 MAJ-2119 MAJ-2116 MAJ-2144 MAJ-2117 MAJ-2118 MAJ-2114 MAJ-2330 MAJ-2115 GF-UC140P-AL5 FB-433D MAJ-1538 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 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 NM-400L-0523 NM-400U-0425 NM-401L-0423 NM-400U-0423 NM-400Y-0423 NM-400U-0523 NM-400L-0421 MAJ-1243 MAJ-1534 MAJ-877 MAJ-1962 MAJ-604 MAJ-1859 MAJ-1875 MAJ-1860 MAJ-1868 MAJ-1929 MAJ-1927 USG-400 MAJ-1742 MAJ-1741 MA-651 MAJ-1632 MB-142 MA-392 MA-474 G-240-2527S G-240-3545A G-240-2527A G-240-2545A G-240-2545S G-240-3527S G-240-3527A G-240-3545S G-260-2545A G-260-2545S G-260-3527S G-260-2527A G-260-3545A G-260-3527A G-260-2527S G-260-3545S CF-HQ190I CF-HQ190L MAJ-1817 CF-H190I CF-H190L PCF-PH190I MAJ-215 PCF-H190L PCF-PH190L PCF-H190I MAJ-1933 CLV-S190 LTF-S190-10 OTV-S190 MAJ-1956 MAJ-1959 MAJ-1939 MAJ-1985 Hysteroscope accessories MAJ-2304 MAJ-2307 MAJ-2308 OME-L200 OME-V200 MAJ-2303 MAJ-2301 BML-V232QR-30 BML-610A MAJ-441 BML-V437QR-30 BML-V232QR-26 BML-V237QR-30 BML-V242QR-30 BML-V442QR-30 MAJ-2502 CYF-5 MAJ-1413 FG-V451P OER-Elite MAJ-840 MAJ-865 MAJ-1025 MH-856 MH-946 MAJ-1026 MAJ-419 MD-227 MAJ-1024 MH-948 MH-944 MH-553 MH-974 PCF-HQ190L PCF-H190TI PCF-HQ190I PCF-H190TL CLV-S45 MAJ-1214 URF-V3R URF-P7 URF-P7R URF-V3 MAJ-901 MAJ-902 GIF-XP190N ENF-VH2 ENF-V4 MB-156 BF-H1100 BF-P190 BF-XP190 BF-1TH1100 BF-XT190 OEV262H MAJ-2315 MH-244 BC-V600P-3010 NM-400L-0525 NM-400L-0621 NM-400U-0623 NM-401L-0523 NM-401L-0623 NM-401L-0525 NM-401L-0425 NM-400L-0623 NM-401L-0625 NM-400U-0525 NM-400U-0323 NM-400L-0423 NM-400U-0625 NM-400L-0625 NM-400L-0425 SIF-Q180 BC-202D-1210 MH-969 MAJ-3 NA-U201H-8019 NA-U201H-8025 NA-U201H-8022 MAJ-864 CYB-2, CYB-3 Sur-Lock MAJ-525 BD-210N-0620 BD-210N-0830 BD-210N-0440 BD-210N-0640 BD-210N-0420 NM-221C-0427 CF-H170I CF-H170L FB-456D 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 MAJ-1218 MAJ-210 MAJ-209 NA-U401SX-4021 NA-U401SX-4022 PR-V427Q PR-V414Q PR-V614M PR-V418Q PR-V435Q PR-V416Q PR-V223Q PR-V420Q PR-V434Q MAJ-1077 MAF-TM2 MAJ-222 MAF-DM2 MAF-GM2 MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories GF-UE190 MAJ-1912 MAJ-1921 Visera Elite II Endoeye 3D MAJ-2316 MAJ-1919 BD-VC431Q-1840-30 BD-VC431Q-1840-25 BD-VC431Q-1840-20 UM-S20-20R UM-S20-17S MAJ-1379 OEV321UH MAJ-350 MAJ-629 KD-VC412Q-0215 K-401 K-402 CYF-VHA MAJ-207 MAJ-2020 MAJ-2009 ALT-Pro MAJ-2052 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 OBCU MAJ-1727 MAJ-1805 ST-SB1 MAJ-1726 MAJ-2549 MAJ-2551 MAJ-2548 MAJ-2550 MAJ-2547 MAJ-669 MH-968 MAJ-2358 UM-3R-3 UM-G20-29R-3 UM-S20-20R-3 MAJ-1196

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility