Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010047

FEI Number

3002807795

Entity Name

OLYMPUS MEDICAL SYSTEMS CORP.

City/State/Country

HACHIOJI-SHI Tokyo, JP

Establishment Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI Tokyo 192-8507, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K102379

PMA Number

N/A

All Registered 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-2511 MAJ-2432 OTV-S200 OTV-S700 CLL-S700 MAJ-2512 CH-S700-XZ-EA 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 OTV-S200 Telescope "ULTRA" CLV-S200-IR MAJ-1414 CH-S190-08-LB 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 SD-230U-20 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 OTV-S500 MAJ-860 SD-210U-15 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 MH-438 FB-211D FB-241D FB-231D FB-221D MH-438 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 MAJ-1869 MH-438 OTV-S7PROH-HD-L08E MD-493 MH-999E 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 MH-999E MAJ-879 MB-358 MAJ-1586 MH-438 MB-155 MAJ-1584 CH-S700-XZ-EA OTV-S700 CLL-S700 MAJ-2512 UHI-4 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 CLV-190 BF-H190 CV-190 3DV-190 MAJ-2053 LTF-190-10-3D MAJ-2054 CV-190 CV-180 MAJ-1464 MAJ-1462 MH-966 MH-999E MAJ-2382 EU-ME3 MAJ-2381 MAJ-2383 MAJ-1720 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 FB-241D FB-211D FB-231D FB-221D D-201-12704 D-201-10704 GIF-XP170N GIF-1TH190 GIF-H170 D-201-11804 D-201-15004 MAJ-2437 GIF-1100 CV-1500 CF-HQ1100DL MAJ-920 MH-985 CF-HQ1100DI MAJ-2431 B5-2C FD-231C MAJ-1443 MAJ-1444 FG-226C FG-220P FG-232L FG-804L FG-214P 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 FD-410LR FD-412LR FD-411UR 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 MAJ-1904 MAJ-1514 MAJ-1515 MAJ-1513 MAJ-1511 MAJ-1516 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 USG-410 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 UCR MAJ-1085 MAJ-1084 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 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 MH-438 CLV-S190 LTF-S190-10 OTV-S190 MAJ-1956 MAJ-1959 MH-999E MAJ-1939 MAJ-1985 Hysteroscope accessories FG-54D FG-52D MAJ-2304 MAJ-2307 MAJ-2308 OME-L200 OME-V200 MAJ-2303 MAJ-2301 MAJ-855 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 KD-612U KD-V411M-0320 KD-V411M-0330 KD-V411M-0720 KD-V411M-0725 KD-V441M TJF-Q190V FG-V451P MAJ-2144 OER-Elite MAJ-840 MAJ-865 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 PCF-HQ190L PCF-H190TI PCF-HQ190I PCF-H190TL CLV-S45 MH-438 MAJ-1214 URF-V3R URF-P7 URF-P7R URF-V3 MAJ-901 MAJ-902 GIF-XP190N MH-438 NA-U401SX-4025N ENF-VH2 ENF-V4 MB-156 FD-412LR FD-411UR BF-H1100 BF-P190 BF-XP190 BF-1TH1100 BF-XT190 OEV262H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-03-08
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
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	2018-09-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-09-10
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-09-29
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2017-01-10
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-09-27
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2016-12-11
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
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2013-08-08
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
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
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
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2008-06-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-06-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
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
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
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	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
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2019-05-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-05-22
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-05-22
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-05-22
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-11-21
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2018-08-17
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2010-02-23
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2025-04-07
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-06-16
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-05-17
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2022-05-17
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
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2019-10-17
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2019-10-17
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-11-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
QEC	Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree	Gastroenterology, Urology	Class 2	876.4300	2019-06-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2008-06-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-16
PSV	Ultrasound Bronchoscope	Radiology	Class 2	892.1550	2008-06-16
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2026-06-16
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
NFI	Device, Hardcopy, Images, Ophthalmic	Radiology	Class 2	892.2040	2023-11-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
BTG	Brush, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-09-30
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2023-11-01
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2022-08-24
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2013-01-09
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
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2008-06-16
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-17
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-01-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-02-22
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2022-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-28
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
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
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2012-02-27
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2011-02-28
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-02-25
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2025-02-25
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-02-25
BTG	Brush, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-08-08
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-11-04
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2020-11-04
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-06-16
FDT	Duodenoscope 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	2013-06-25
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-12-16
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
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-03-03
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2006-12-01
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-06-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-12-10
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2006-12-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-11-17
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
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2009-07-27
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-11-20
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
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
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2009-03-09
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
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	2006-12-01
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-12-01
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-12-01
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
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
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
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2013-05-22
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
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-02
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2008-03-03
QGE	Biliary Stent, Drain, And Dilator Accessories	Gastroenterology, Urology	Class 1	876.5012	2023-11-16
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-06-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2008-06-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-10-30
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2017-12-19
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
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2013-06-25
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-06-25
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2013-06-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-06-25
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-06-17
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
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
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
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-10-17
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2025-11-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2024-06-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
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
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2021-01-27
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-01-27
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2026-04-08
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2009-03-19
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2017-03-01
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2008-06-16
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
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-06-13
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2019-06-17
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-07-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-12-20
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-06-16
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2022-04-04
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-10-30
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	2020-03-09
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-03-09
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-11-16
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-11-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-11-16
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-11-20
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2011-02-28
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-03-29
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
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
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
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-04-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2022-08-25
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2006-12-01
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-09-03
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-10-30
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
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-16
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2008-03-03
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-11-17
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-02-03
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-06-16
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2008-06-16
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2011-06-06
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
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2016-02-23
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2010-01-29
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
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2016-03-01
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-03-01
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
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
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2012-10-22
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2008-06-19
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2020-02-13
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2020-02-13
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-12-09
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-17
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2019-10-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-10-17
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	Class 2	876.4500	2019-12-05
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-10-30
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-06-17
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2022-06-22
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-20
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2018-03-14
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2018-03-14
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-09-01
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-07-20
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2020-07-20
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2021-11-14
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2006-01-31
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	2022-09-27
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-02-07
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-02-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2019-02-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-17
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	2013-08-08
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-08-08
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2020-02-02
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
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	2025-06-26
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2007-11-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-28

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
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K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010047. Last updated year: 2026. Please use registration number 8010047 when referencing this establishment in official correspondence.