Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808148

FEI Number

3002808148

Entity Name

SHIRAKAWA OLYMPUS CO., LTD.

City/State/Country

NISHISHIRAKAWA-GUN Fukushima, JP

Establishment Address

3-1 Okamiyama, Odakura, NISHIGO-MURA, NISHISHIRAKAWA-GUN Fukushima 961-8061, 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

Expiration Date (Year)

2026

510(k) Number

K121959

PMA Number

N/A

All Registered Proprietary Names

CV-180 MAJ-1464 MAJ-1462 MH-966 MH-999E CYF-VHA CYF-5 CYF-VH MAJ-207 CYF-VHR CYF-V2 CYF-V2R CYF-VH MAJ-669 MH-968 MH-999E CH-S700-XZ-EA OTV-S700 CLL-S700 MAJ-2512 MAJ-902 MAJ-901 MAJ-2437 GIF-1100 CV-1500 CF-HQ1100DL MAJ-920 MH-985 CF-HQ1100DI MAJ-2431 UM-3R UM-G20-29R MAJ-1995 MAJ-1919 CYF-5 MAJ-1413 MAJ-1218 MAJ-210 MAJ-209 MH-966 CV-180 MAJ-1934 MAJ-1957 Telescope "IR" CH-S200-XZ-EB CH-S200-XZ-EA OTV-S200 Telescope "ULTRA" CLV-S200-IR CV-190 CLV-190 CF-HQ190I CF-HQ190L MAJ-1817 CF-H190I CF-H190L PCF-PH190I MAJ-215 PCF-H190L PCF-PH190L PCF-H190I MAJ-1933 MH-438 OTV-S500 MAJ-2295 BF-UC190F CH-S400-XZ-EB CH-S400-XZ-EA MAJ-1742 MAJ-1741 UCR MAJ-1085 MAJ-1084 MAJ-1196 MAJ-1878 MAJ-1898 UPD-3 MAJ-1899 MAJ-1907 MAJ-1880 MAJ-1879 MAJ-1938 MAJ-1881 MAJ-1890 MH-985 MAJ-2431 MAJ-2437 CV-1500 MAJ-920 CV-170 USG-410 TD-410 MAJ-2467 TB2-0535FC TB2-0520FC TB2-0545FC TB2-0525FC UM-S20-20R UM-S20-17S MAJ-2382 EU-ME3 MAJ-2381 MAJ-2383 MAJ-1720 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-864 CH-S190-08-LB MAJ-1939 MAJ-1985 MH-244 MAJ-1025 MH-856 MH-946 MAJ-1026 MAJ-419 MD-227 MAJ-1024 MH-948 MH-966 MH-944 MH-438 MH-553 MH-974 MAJ-1352 CLV-S45 MAJ-1830 MAJ-1831 MAJ-438 AR-TZ2 MH-999E MH-984 AR-T12Q 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 OEV262H MAJ-854 MH-995 MAJ-2268 MAJ-2251 UCES-4 MAJ-2528 MAJ-2316 UHI-3 MAJ-1080 MAJ-1084 MAJ-1085 UCR MAJ-901 MAJ-902 MAJ-1443 MAJ-1444 OEV321UH CLV-S190 LTF-S190-10 OTV-S190 MAJ-1956 MAJ-1959 MH-999E GF-UCT180 MAJ-350 MAJ-629 MAJ-1443 MAJ-1444 UM-3R-3 UM-S20-17S UM-G20-29R-3 UM-S20-20R-3 CH-S190-XZ-Q MAJ-2363 OTV-SI CV-1500 MAJ-2511 MAJ-2432 OTV-S200 OTV-S700 CLL-S700 MAJ-2512 CH-S700-XZ-EA CH-S190-08-LB MAJ-1912 MAJ-1921 Visera Elite II Endoeye 3D MAJ-2316 MAJ-2549 MAJ-2551 OTV-S500 MAJ-2548 MAJ-2550 MAJ-2547 GF-UE190 OIP-1 UHI-4 MAJ-1948 MAJ-1942 BF-Q170 BF-1TQ170 FB-19SX-1 FB-221D FB-241D CLV-190 FB-231D UWIT-TX UWIT-RX MAJ-2011 MAJ-1945 ENF-V3 ENF-VH ENF-GP2 OTV-S700 MAJ-2511 CH-S700-XZ-EA CLL-S700 ENF-VH2 ENF-V4 MB-156 BF-1TH190 BF-Q190 CLV-190 BF-H190 CV-190

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-08-21
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2014-08-21
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2017-03-01
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-02
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-11-17
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2025-11-17
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-11-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-11-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-06-28
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2023-06-28
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-06-28
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-06-28
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2023-06-28
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-09-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-09-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-15
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-11-15
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-09
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	1995-08-28
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-16
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-06-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2020-07-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-07-21
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-07-21
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2020-07-21
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2020-07-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-06-17
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2024-09-02
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2024-09-02
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-09-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-02-01
PSV	Ultrasound Bronchoscope	Radiology	Class 2	892.1550	2021-02-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-02-01
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-28
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2017-11-28
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2006-12-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	1995-10-18
PGU	Spatial Imaging For Display Of Endoscope Position	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-06-29
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2023-06-29
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-06-29
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-06-29
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2023-06-29
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-06-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-11-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-07-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-02-17
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-02-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-02-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-02-17
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
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-06-16
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2011-12-16
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2011-12-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2019-03-21
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
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2021-11-14
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-06-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-06-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-06-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-06-25
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2013-06-25
ODA	Endoscopic Central Control Unit	Gastroenterology, Urology	Class 2	876.1500	2010-04-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-04-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
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
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2012-05-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-28
NFI	Device, Hardcopy, Images, Ophthalmic	Radiology	Class 2	892.2040	2023-11-17
ODA	Endoscopic Central Control Unit	Gastroenterology, Urology	Class 2	876.1500	2018-09-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-09-10
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-09-08
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2019-09-08
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-06-16
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-09-27
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2013-02-22
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-02-22
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2013-02-22
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-11-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-03-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2013-01-07
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-01-07
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2013-01-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-07-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-07-12
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2010-07-12
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2010-07-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-07-12
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-07-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-03-28
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-04-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-04-06
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2020-04-06
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2020-04-06
GCM	Endoscope, Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-04-06
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-03-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-03-12
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2025-03-12
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-03-12
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2025-03-12
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2025-03-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-16
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-11-16
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2016-02-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-18
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-02-18
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2016-02-18
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2016-02-18
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-02-18
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-10-17
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2023-11-01
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2013-08-05
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-08-05
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2013-08-05
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-07-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2022-09-27
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2022-09-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-06-17
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-11-20
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-04-15
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-04-15
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2019-02-19
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2019-02-19
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2013-06-25
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2013-06-25

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
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
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K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K191144	Mauna Kea Technologies	Cellvizio 100 Series System with Confocal Miniprobes	2020-01-24

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Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808148. Last updated year: 2026. Please use registration number 3002808148 when referencing this establishment in official correspondence.