Olympus Medical Systems Corp.
Hachioji-Shi, JP
OLYMPUS MEDICAL SYSTEMS CORP. appears in FDA device records in Hachioji-Shi, JP. FDA records list 186 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 186FDA records hold 186 510(k) clearances for Olympus Medical Systems Corp. between 2004 and 2026. The busiest year on record is 2025, with 32. The most recent is 2026, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 8 |
| 2006 | 6 |
| 2007 | 4 |
| 2008 | 10 |
| 2009 | 5 |
| 2010 | 7 |
| 2011 | 6 |
| 2012 | 12 |
| 2013 | 8 |
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 6 |
| 2017 | 8 |
| 2018 | 11 |
| 2019 | 14 |
| 2020 | 14 |
| 2021 | 5 |
| 2022 | 7 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 32 |
| 2026 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | Substantially Equivalent | |
| K254056 | THUNDERBEAT 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) | GEI | Substantially Equivalent | |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | FET | Substantially Equivalent | |
| K260580 | Single 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) | PKL | Substantially Equivalent | |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | EOQ | Substantially Equivalent | |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | EOB | Substantially Equivalent | |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | KGE | Substantially Equivalent | |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | FDT | Substantially Equivalent | |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | FDX | Substantially Equivalent | |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | KNS | Substantially Equivalent | |
| K251336 | VISERA 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) | OWN | Substantially Equivalent | |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | FCG | Substantially Equivalent | |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | FGE | Substantially Equivalent | |
| K250945 | Single 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) | KNS | Substantially Equivalent | |
| K252247 | Injector 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) | FBK | Substantially Equivalent | |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | KNS | Substantially Equivalent | |
| K252150 | Ultrasonic 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) | GEI | Substantially Equivalent | |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | KGE | Substantially Equivalent | |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | Substantially Equivalent | |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | OCX | Substantially Equivalent | |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | OCX | Substantially Equivalent | |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | FDT | Substantially Equivalent | |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | ITX | Substantially Equivalent | |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | KTI | Substantially Equivalent | |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | ODC | Substantially Equivalent | |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | ITX | Substantially Equivalent | |
| K250862 | EVIS 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) | EOQ | Substantially Equivalent | |
| K251279 | Disposable Cytology Brush BC-202D/203D Series | BTG | Substantially Equivalent | |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | FDT | Substantially Equivalent | |
| K250118 | Disposable Balloon Catheter B5-2C | EOQ | Substantially Equivalent | |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | EOQ | Substantially Equivalent | |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | ODD | Substantially Equivalent | |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | FDF | Substantially Equivalent | |
| K250296 | Disposable Distal Attachment D-201 Series | FDS | Substantially Equivalent | |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | KTI | Substantially Equivalent | |
| K241842 | Luer-Split MAJ-2092 | ODC | Substantially Equivalent | |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | LQR | Substantially Equivalent | |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | EOB | Substantially Equivalent | |
| K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | IYN | Substantially Equivalent | |
| K243527 | High Flow Insufflation Unit (UHI-4) | HIF | Substantially Equivalent | |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | OCX | Substantially Equivalent | |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | FET | Substantially Equivalent | |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | FDS | Substantially Equivalent | |
| K240617 | Single 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) | PKL | Substantially Equivalent | |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | EOQ | Substantially Equivalent | |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | FET | Substantially Equivalent | |
| K221683 | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) | FAJ | Substantially Equivalent | |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | FAJ | Substantially Equivalent | |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | EOB | Substantially Equivalent | |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | EOQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010047 | 3002807795 | OLYMPUS MEDICAL SYSTEMS CORP. | 2951 ISHIKAWA-CHO, HACHIOJI-SHI Tokyo 192-8507 JP | 2026 | and 64 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FEBAccessories, Cleaning, For Endoscope
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- KTIBronchoscope Accessory
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- KQMCamera, Surgical And Accessories
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- NFIDevice, Hardcopy, Images, Ophthalmic
- FFLDislodger, Stone, Basket, Ureteral, Metal
- LQRDislodger, Stone, Biliary
- FDTDuodenoscope And Accessories, Flexible/Rigid
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NWBEndoscope, Accessories, Narrow Band Spectrum
- GCMEndoscope, Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- MNKEndoscopic Bite Block
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FDAEnteroscope And Accessories
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- NWWHysteroscope Accessories
- LFLInstrument, Ultrasonic Surgical
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- EQLLaryngostroboscope
- NTNLed Light Source
- MNDLigator, Esophageal
- GCTLight Source, Endoscope, Xenon Arc
- LQCLithotriptor, Biliary Mechanical
- EPTMicroscope, Surgical
- EOBNasopharyngoscope (Flexible Or Rigid)
- GAANeedle, Aspiration And Injection, Disposable
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- EQHSource, Carrier, Fiberoptic Light
- FGEStents, Drains And Dilators For The Biliary Ducts
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IZISystem, X-Ray, Angiographic
- JAKSystem, X-Ray, Tomography, Computed
- ITXTransducer, Ultrasonic, Diagnostic
- GCWTransformer, Endoscope
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain