Data / Medical devices / Japan / Shirakawa Olympus Co., Ltd.
Shirakawa Olympus Co., Ltd.: FDA-registered device maker in NISHISHIRAKAWA-GUN Fukushima, Japan, 85 510(k) clearances
Shirakawa Olympus Co., Ltd. is registered with the FDA (registration 3002808148) in NISHISHIRAKAWA-GUN Fukushima, Japan. It lists 41 device types. The FDA files 85 510(k) clearances under its listings, the newest dated September 10, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002808148
- Address
- 3-1 Okamiyama, Odakura NISHIGO-MURA, NISHISHIRAKAWA-GUN Fukushima, Japan, 961-8061
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- October 18, 1995
- Registered through
- 2027
- Brand names listed
- ALT-Pro, BF-1TH190, BF-H190, BF-UC190F, BW-400B, BW-400L, BW-400V, BW-403B 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 |
|---|---|---|---|---|---|---|
| September 10, 2026 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | FET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| July 31, 2026 | K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 24, 2026 | K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | FET | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| November 12, 2025 | 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 | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 7, 2025 | 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 | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 3, 2025 | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| September 18, 2025 | K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | ITX | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 16, 2025 | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | ODC | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 11, 2025 | K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | ITX | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| April 2, 2025 | K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | FET | Substantially Equivalent | Olympus Corporations of the Americas | accessdata.fda.gov |
| March 3, 2025 | K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | EOB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| January 17, 2025 | K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | IYN | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| January 13, 2025 | K243527 | High Flow Insufflation Unit (UHI-4) | HIF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 7, 2024 | K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | OCX | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 3, 2024 | K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | FET | 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 |
| January 20, 2023 | 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 | 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 |
| September 2, 2022 | K221557 | Visera Hysterovideoscope Olympus HYF Type V | HIH | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| August 4, 2021 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | LFL | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| November 9, 2020 | K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS | IYN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 29, 2020 | K202646 | Visera Elite II Video System Center | FET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| July 17, 2020 | K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head | OWN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 3, 2020 | K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 6, 2019 | K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | PSV | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 6, 2019 | K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 30, 2019 | K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | FET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 5, 2019 | K183053 | Olympus Small Intestinal Capsule Endoscope System | NEZ | 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 |
| October 4, 2018 | K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 5, 2017 | K172618 | SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 17, 2017 | K172817 | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA | FET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 19, 2017 | K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | NEZ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 1, 2015 | K151011 | VISERA 4K UHD SYSTEM | HET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 7, 2014 | K133538 | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE | NWB | Substantially Equivalent | Olympus Corporation of the Americas | 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 |
| April 29, 2013 | K123421 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | NEZ | 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 |
| February 22, 2013 | K130058 | ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 | IYN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 4, 2013 | K123704 | AUTOMATED ENDOSCOPE LEAK TESTER | PCV | 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 14, 2012 | K122831 | VIDEO SYSTEM CENTER | NTN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| November 13, 2012 | K122180 | HIGH FLOW INSUFFLANTION UNIT | HIF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| August 10, 2012 | K120278 | WIRELESS IMAGE TRANSMITTER UNIT | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | 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 |
| November 18, 2011 | K110294 | HIGH FLOW INSUFFLATION UNIT UHI-4 | HIF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 12, 2011 | K103312 | UPD-Y0003 | FDF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 8, 2010 | K102059 | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | FET | 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 |
| March 22, 2010 | K100345 | SYSTEMS INTEGRATION MODEL: ENDOALPHA | ODA | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| March 10, 2010 | K093507 | OLYMPUS CHF TYPE Y0003 | FBN | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| January 13, 2009 | K083155 | HD CAMERA HEAD OTV-S7PROH-HD-L08E | FET | 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 |
| March 18, 2008 | K072957 | EVIS EXERA II 180 SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 5, 2007 | K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | PSV | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| March 5, 2007 | K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | FCX | 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 |
| September 22, 2006 | K062049 | EVIS EXERA II 180 SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| August 31, 2006 | K061313 | EVIS EXERA 180 SYSTEM | EOQ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 26, 2006 | K053382 | LAPARO-THORACO VIDEOSCOPE XLTF-VAW | GCJ | 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 |
| July 1, 2005 | K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | FDF | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| June 3, 2005 | K050885 | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG | LFL | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| September 8, 2004 | K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | Aomori Olympus Co., Ltd. | accessdata.fda.gov |
| August 18, 2004 | K042140 | OLYMPUS BF TYPE UC160-OL8 | ODG | Substantially Equivalent | Olympus Corporation | accessdata.fda.gov |
| March 24, 2003 | K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | KNS | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| June 25, 2002 | K014166 | UHI-3 HIGH FLOW INSUFFLATION UNIT | HIF | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| June 19, 2002 | K021886 | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P | FDS | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| August 27, 2001 | K011886 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, | ODG | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 15, 2001 | K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER | ODG | Substantially Equivalent | Olympus Optical Co., Ltd. | 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 |
| May 26, 2000 | K001203 | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT | ITX | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| December 11, 1998 | K982323 | OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE | ITX | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| June 8, 1998 | K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT | EOQ | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| July 25, 1997 | K971660 | OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT | FDS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| July 16, 1997 | K971416 | OLYMPUS OES OTV-S5C VIDEO SYSTEM | FET | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| April 15, 1996 | K951994 | OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER | IYO | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 29, 1996 | K954451 | EVIS 140 SYSTEM | FET | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 1, 1996 | K955404 | OTV-S5 OES VIDEO SYSTEM | GCJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| December 19, 1995 | K953162 | OLYMPUS HIGH FLOW INSUFFLATION UNIT | HIF | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| April 10, 1995 | K944610 | OLYMPUS ULTRASONIC PROBES | ITX | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| October 7, 1993 | K931154 | EVIS 200 SYSTEM | EOQ | 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 |
|---|---|---|---|---|---|---|
| December 4, 2023 | 93583 | Class II | Ongoing | Model No. CYF-5, Cystonephrofiberscope | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Endoscope, Accessories, Narrow Band Spectrum
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Insufflator, Laparoscopic
- All makers of Insufflator, Endoscopic Vessel Harvesting
- All makers of Insufflator, Automatic Carbon-Dioxide For Endoscope
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.