Data / Medical devices / Japan / Aizu Olympus Co., Ltd.
Aizu Olympus Co., Ltd.: FDA-registered device maker in AIZUWAKAMATSU-SHI Fukushima, Japan, 62 510(k) clearances
Aizu Olympus Co., Ltd. is registered with the FDA (registration 9610595) in AIZUWAKAMATSU-SHI Fukushima, Japan. It lists 29 device types. The FDA files 62 510(k) clearances under its listings, the newest dated August 27, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610595
- FEI number
- 3002964398
- Address
- 3-1-1 Niiderakita, AIZUWAKAMATSU-SHI Fukushima, Japan, 965-8520
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- January 20, 1995
- Registered through
- 2027
- Brand names listed
- BF-1TH1100, BF-1TH190, BF-H1100, BF-H190, BF-P190, BF-XP190, BF-XT190, BW-400B and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2026 | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | FDS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| April 23, 2026 | 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 | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 26, 2025 | K251986 | AUXILIARY WATER TUBE MAJ-855 | OCX | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| September 19, 2025 | K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 23, 2025 | 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 | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 5, 2025 | K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| May 15, 2025 | K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | FDF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| March 19, 2025 | K241842 | Luer-Split MAJ-2092 | ODC | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 19, 2024 | K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | FDS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 15, 2023 | K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | EOQ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| April 26, 2023 | K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | FET | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| December 29, 2022 | K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | FAJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 28, 2022 | K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 26, 2022 | K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 19, 2022 | K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| May 11, 2022 | K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 17, 2021 | K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | HET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 26, 2021 | K201300 | Airway Mobilescope | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 21, 2021 | K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 8, 2020 | K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 1, 2020 | K201920 | Endoscope Reprocessor OER-Elite | FEB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| July 17, 2020 | K192793 | Evis 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-HQ190I | FDF | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 5, 2019 | K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| July 9, 2019 | K190969 | ENDOSCOPE REPROCESSOR OER-Elite | FEB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 6, 2019 | K182102 | RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 16, 2019 | K181451 | URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R | FGB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 30, 2018 | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 30, 2018 | K172246 | OLYMPUS URF-V2/V2R | FGB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 15, 2016 | K143153 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 7, 2014 | K134026 | ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT | PGU | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 29, 2013 | K131780 | EVIS EXERA III VIDEO SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 1, 2013 | K123365 | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | HET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 10, 2013 | K121959 | EVIS EXERA III VIDEO SYSTEM | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 20, 2012 | K120357 | ENDOSCOPE REPROCESSOR OER-MINI | FEB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 11, 2012 | K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | FDS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| April 20, 2012 | K111425 | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | HET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 20, 2012 | K111756 | V1 SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 16, 2012 | K112680 | EVIS EXERA III VIDEO SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| February 23, 2011 | K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | FEB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 14, 2010 | K101053 | OLYMPUS CF TYPE Y0023-L, Y0023I | FDF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 2, 2010 | K100584 | EVIS EXERAII 180 SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 17, 2010 | K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE | IYN | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 20, 2008 | K080403 | XTJF TYPE Q160VF1 | FDT | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| March 25, 2008 | K071254 | SMALL INTESTINAL VIDEOSCOPE SYSTEM | FDA | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| February 8, 2007 | K063683 | OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE | IYN | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 13, 2005 | K051645 | EVIS EXERA 160A SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| January 28, 2005 | K043487 | EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 | FDF | Substantially Equivalent | Aizu Olympus Co., Ltd. | accessdata.fda.gov |
| December 20, 2002 | K024033 | XTJF-160AF DUODENOVIDEOSCOPE | FDT | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| January 30, 2002 | K013617 | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS | GCJ | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| December 26, 2001 | K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT | EOB | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| August 10, 2001 | K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | EOQ | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| July 25, 2001 | K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | EOB | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| May 15, 2001 | K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | FDS | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| January 30, 2001 | K002231 | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT | FDS | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| September 8, 2000 | K001766 | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE | FDS | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| May 9, 2000 | K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | FDF | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| April 21, 1998 | K980465 | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS | FDT | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 29, 1996 | K954451 | EVIS 140 SYSTEM | FET | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 7, 1991 | K912120 | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE | FBN | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| April 29, 1991 | K910423 | BRONCHOSCOPE BF-N20 | EOQ | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| March 27, 1991 | K904799 | CHF-B20 CHOLEDOCHOSCOPE | FBN | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| January 3, 1985 | K843084 | OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE | FBO | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 31, 2025 | 97849 | Class II | Ongoing | Olympus OER-Elite | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. | accessdata.fda.gov |
| October 16, 2023 | 93335 | Class II | Ongoing | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to conta | accessdata.fda.gov |
| September 25, 2023 | 93222 | Class II | Ongoing | Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | accessdata.fda.gov |
| July 20, 2022 | 90664 | Class II | Terminated | EVIS EXERA III Bronchovideoscope | The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner. | accessdata.fda.gov |
Compare with other makers
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- All makers of Endoscope, Accessories, Narrow Band Spectrum
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of Duodenoscope And Accessories, Flexible/Rigid
Updated August 27, 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.