Data / Medical devices / Japan / OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant
OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant: FDA-registered device maker in NISHITAMA-GUN Tokyo, Japan, 17 510(k) clearances
OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant is registered with the FDA (registration 3003637092) in NISHITAMA-GUN Tokyo, Japan. It lists 15 device types. The FDA files 17 510(k) clearances under its listings, the newest dated August 27, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3003637092
- Address
- 34-3 Hirai, Hinode-machi, NISHITAMA-GUN Tokyo, Japan, 190-0182
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- December 1, 2006
- Registered through
- 2027
- Brand names listed
- BF-UCP190F, CYF-5, CYF-VH, CYF-VHA, GF-UC140P-AL5, GF-UE160-AL5, MAJ-1218, MAJ-1555 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 | K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | PSV | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| February 22, 2026 | K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 25, 2025 | K251997 | Single-Use Biopsy Valve (MAJ-1555) | OCX | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 11, 2022 | K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 10, 2019 | K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | IZI | 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 |
| January 19, 2017 | K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | NEZ | 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 |
| 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 |
| August 31, 2006 | K061313 | EVIS EXERA 180 SYSTEM | EOQ | 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 |
| 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 |
| 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 |
| November 16, 1998 | K982610 | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) | ITX | Substantially Equivalent | Olympus Optical, Co. | accessdata.fda.gov |
| April 10, 1995 | K944610 | OLYMPUS ULTRASONIC PROBES | ITX | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
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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.