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Data / Medical devices / Japan / Olympus Medical Systems Corp.

Olympus Medical Systems Corp.: FDA-registered device maker in HACHIOJI-SHI Tokyo, Japan, 217 510(k) clearances

Olympus Medical Systems Corp. is registered with the FDA (registration 8010047) in HACHIOJI-SHI Tokyo, Japan. It lists 74 device types. The FDA files 217 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Olympus Medical Systems Corp.
FDA registration number
8010047
FEI number
3002807795
Address
2951 Ishikawa-Cho, HACHIOJI-SHI Tokyo, Japan, 192-8507
Owner or operator
OLYMPUS CORPORATION (9067818)
Roles
Exporter to the US, Specification developer
First device listed
January 20, 1995
Registered through
2027
Brand names listed
ALT-Pro, B-V233P-A, B-V233P-B, B-V243Q-A, B-V243Q-B, B-V433P-A, B-V433P-B, B-V443Q-A and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Specification developeraccessdata.fda.gov
Accessories, Cleaning, For EndoscopeFEB2Specification developeraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Specification developeraccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Specification developeraccessdata.fda.gov
Biliary Stent, Drain, And Dilator AccessoriesQGE1Specification developeraccessdata.fda.gov
Biopsy NeedleFCG2Specification developeraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Specification developeraccessdata.fda.gov
Bronchoscope AccessoryKTI2Specification developeraccessdata.fda.gov
Brush, Biopsy, Bronchoscope (Non-Rigid)BTG2Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Specification developeraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Specification developeraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Specification developeraccessdata.fda.gov
Confocal Optical ImagingOWN2Specification developeraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Specification developeraccessdata.fda.gov
CystourethroscopeFBO2Specification developeraccessdata.fda.gov
Device, Hardcopy, Images, OphthalmicNFI2Specification developeraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Specification developeraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Specification developeraccessdata.fda.gov
Duodenoscope And Accessories, Flexible/RigidFDT2Specification developeraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the US, Specification developeraccessdata.fda.gov
Endoscope Channel AccessoryODC2Specification developeraccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Specification developeraccessdata.fda.gov
Endoscope, RigidGCM2Specification developeraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Specification developeraccessdata.fda.gov
Endoscopic Bite BlockMNK1Specification developeraccessdata.fda.gov
Endoscopic Central Control UnitODA2Specification developeraccessdata.fda.gov
Endoscopic Cytology BrushFDX2Specification developeraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZ2Specification developeraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Specification developeraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Exporter to the USaccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Specification developeraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Specification developeraccessdata.fda.gov
Endoscopic Leak TesterPCV2Specification developeraccessdata.fda.gov
Endoscopic Retrograde Cholangiopancreatography (Ercp) CannulaODD2Specification developeraccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Specification developeraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Specification developeraccessdata.fda.gov
Enteroscope And AccessoriesFDA2Specification developeraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Specification developeraccessdata.fda.gov
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial TreeQEC2Specification developeraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Specification developeraccessdata.fda.gov
Gastrointesinal Lesion Software Detection SystemQNP2Specification developeraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Specification developeraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Specification developeraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Specification developeraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Specification developeraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUSpecification developeraccessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For EndoscopeFCX2Specification developeraccessdata.fda.gov
Insufflator, Endoscopic Vessel HarvestingOSV2Specification developeraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the US, Specification developeraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Specification developeraccessdata.fda.gov
LaryngostroboscopeEQL1Specification developeraccessdata.fda.gov
Led Light SourceNTN2Specification developeraccessdata.fda.gov
Ligator, EsophagealMND2Specification developeraccessdata.fda.gov
Light Source, Endoscope, Xenon ArcGCT2Specification developeraccessdata.fda.gov
Lithotriptor, Biliary MechanicalLQC2Specification developeraccessdata.fda.gov
Microscope, SurgicalEPT1Specification developeraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Specification developeraccessdata.fda.gov
Snare, FlexibleFDI2Specification developeraccessdata.fda.gov
Snare, Non-ElectricalFGX1Specification developeraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Specification developeraccessdata.fda.gov
Spatial Imaging For Display Of Endoscope PositionPGU2Specification developeraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Specification developeraccessdata.fda.gov
System, Imaging, Gastrointestinal, Wireless, CapsuleNEZ2Specification developeraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Specification developeraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Specification developeraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Specification developeraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Specification developeraccessdata.fda.gov
Transformer, EndoscopeGCW2Specification developeraccessdata.fda.gov
Ultrasound BronchoscopePSV2Specification developeraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Specification developeraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 217.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 10, 2026K2620794K Camera Head OLYMPUS CH-S700-08-LBFETSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
August 27, 2026K260856Disposable Distal Attachment D-201-13404FDSSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
August 27, 2026K260824Gastrointestinal Videoscope Olympus GIF-2T1500FDSSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
August 27, 2026K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)PSVSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
August 26, 2026K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJSubstantially EquivalentSony Corporationaccessdata.fda.gov
July 31, 2026K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODGSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 17, 2026K261614LED LCD Monitor (OEV-271H)GCJSubstantially EquivalentLg Electronics.Incaccessdata.fda.gov
July 1, 2026K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)GEISubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
June 24, 2026K261260HD Camera Head OLYMPUS CH-S200-08-LBFETSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
May 21, 2026K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)PKLSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 23, 2026K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)EOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 20, 2026K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOBSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
March 6, 2026K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRKGESubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
February 22, 2026K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)FDTSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 18, 2025K250993Single Use Cytology Brush V (BC-V600P-3010)FDXSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
November 25, 2025K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNSSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
November 12, 2025K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)OWNSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 24, 2025K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCGSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 21, 2025K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)FGESubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 17, 2025K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)KNSSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 16, 2025K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)FBKSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 10, 2025K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)KNSSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 7, 2025K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)GEISubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 7, 2025K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)KGESubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 3, 2025K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODGSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
September 26, 2025K251986AUXILIARY WATER TUBE MAJ-855OCXSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
September 25, 2025K251997Single-Use Biopsy Valve (MAJ-1555)OCXSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
September 19, 2025K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)FDTSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 18, 2025K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)ITXSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 29, 2025K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)KTISubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 16, 2025K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODCSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 11, 2025K250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)ITXSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
June 23, 2025K250862EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)EOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
June 12, 2025K251279Disposable Cytology Brush BC-202D/203D SeriesBTGSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
June 5, 2025K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDTSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
June 4, 2025K250118Disposable Balloon Catheter B5-2CEOQSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
May 30, 2025K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)EOQSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
May 27, 2025K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MODDSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
May 15, 2025K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)FDFSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
May 1, 2025K250296Disposable Distal Attachment D-201 SeriesFDSSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 2, 2025K242067VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EAFETSubstantially EquivalentOlympus Corporations of the Americasaccessdata.fda.gov
March 31, 2025K250263Disposable Grasping Forceps FG-52D/FG-54DKTISubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 19, 2025K241842Luer-Split MAJ-2092ODCSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
March 18, 2025K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432PLQRSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 3, 2025K243380VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)EOBSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
January 17, 2025K243502EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)IYNSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
January 13, 2025K243527High Flow Insufflation Unit (UHI-4)HIFSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 3, 2024K241371VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)FETSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
June 19, 2024K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190FDSSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
June 3, 2024K240617Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)PKLSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
June 15, 2023K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100EOQSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
April 26, 2023K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100FETSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
January 20, 2023K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)FAJSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
December 29, 2022K221690OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)FAJSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 28, 2022K221660RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XPEOBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 26, 2022K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type VEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 19, 2022K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3EOBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 2, 2022K221557Visera Hysterovideoscope Olympus HYF Type VHIHSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
May 11, 2022K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDTSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 9, 2022K2200694K UHD LCD Monitor OEV321UHGCJSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 22, 2021K212667Single Use Guide Sheath Kit-401, K-402EOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 17, 2021K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HETSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
August 4, 2021K211838Ultrasonic Bipolar Generator USG-410 with accessoriesLFLSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
January 26, 2021K201300Airway MobilescopeEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
January 21, 2021K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190EOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 17, 2020K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804LEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 8, 2020K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDTSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
November 9, 2020K203128EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUSIYNSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 29, 2020K202646Visera Elite II Video System CenterFETSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 1, 2020K201920Endoscope Reprocessor OER-EliteFEBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
July 17, 2020K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera HeadOWNSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
July 17, 2020K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190IFDFSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 28, 2020K192498Single Use InjectorFBKSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 24, 2020K200397Single Use Biopsy Forceps FB-456DEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 3, 2020K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DGCJSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 6, 2020K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DREOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 17, 2019K193039Single Use Balloon Dilator V (with knife)KNSSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 10, 2019K190239Single Use Aspiration NeedleKTISubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 10, 2019K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IRIZISubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 6, 2019K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FPSVSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 6, 2019K183416Rhino-Laryngo Videoscope Olympus ENF-VT3EOBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 5, 2019K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190EOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
August 30, 2019K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera HeadFETSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
August 2, 2019K190293Single Use Cytology Brush BC-205DBTGSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
July 9, 2019K190969ENDOSCOPE REPROCESSOR OER-EliteFEBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
May 15, 2019K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645KNSSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 5, 2019K183053Olympus Small Intestinal Capsule Endoscope SystemNEZSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
February 6, 2019K182102RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4EOBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
January 16, 2019K181451URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7RFGBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
November 30, 2018K173495Single Use Hot Biopsy Forceps FD-231QECSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
November 15, 2018K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NFCGSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 31, 2018K181994Single Use Aspiration Needle NA-U201HFCGSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 4, 2018K181240Rhino-Laryngo Fiberscope Olympus ENF-GP2EOBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
June 8, 2018K180449Single Use Aspiration Needle NA-U200HFCGSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 30, 2018K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 30, 2018K172246OLYMPUS URF-V2/V2RFGBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 7, 2017K172734Single Use Electrosurgical Snare SD-400FDISubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 5, 2017K172618SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1GCJSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
November 27, 2017K170811Single Use Retrieval Nitinol Basket VLQRSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
November 17, 2017K171158Single Use Electrosurgical knifeKNSSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov

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Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.