Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
SHIRAKAWA OLYMPUS CO., LTD. appears in FDA device records in NISHISHIRAKAWA-GUN Fukushima, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002808148 | 3002808148 | SHIRAKAWA OLYMPUS CO., LTD. | 3-1 Okamiyama, Odakura, NISHISHIRAKAWA-GUN Fukushima 961-8061 JP | 2026 | and 31 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
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- EOQBronchoscope (Flexible Or Rigid)
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- OWNConfocal Optical Imaging
- FAJCystoscope And Accessories, Flexible/Rigid
- NFIDevice, Hardcopy, Images, Ophthalmic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- NWBEndoscope, Accessories, Narrow Band Spectrum
- GCMEndoscope, Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- ODAEndoscopic Central Control Unit
- OCXEndoscopic Irrigation/Suction System
- PCVEndoscopic Leak Tester
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FDAEnteroscope And Accessories
- QNPGastrointesinal Lesion Software Detection System
- FDSGastroscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- LFLInstrument, Ultrasonic Surgical
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- OSVInsufflator, Endoscopic Vessel Harvesting
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- EQLLaryngostroboscope
- NTNLed Light Source
- GCTLight Source, Endoscope, Xenon Arc
- EOBNasopharyngoscope (Flexible Or Rigid)
- PGUSpatial Imaging For Display Of Endoscope Position
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- GCWTransformer, Endoscope
- PSVUltrasound Bronchoscope
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0692-2024 | Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0691-2024 | Model No. CYF-V2, VISERA Cysto-Nephro Videoscope | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0690-2024 | Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0689-2024 | Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0688-2024 | Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0687-2024 | Model No. BF-XP190, EVIS EXERA III Bronchovideoscope | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0686-2024 | Model No. BF-P190, EVIS EXERA III Bronchovideoscope | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0685-2024 | Model No. CYF-5R, Cystonephrofiberscope | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | Class II | Open, Classified | |
| Z-0684-2024 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain