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Sign in to claim this brandOlympus Medical Systems Corporation
US
Last updated May 23, 2026
What Olympus Medical Systems Corporation makes
The company manufactures single-use and reusable endoscopic devices, including non-bioabsorbable polymeric biliary stents, disposable biopsy forceps, and single-use sphincterotomes. It also produces reusable endoscopic tools such as video colonoscopes, flushing tubing sets, and electrical connection cables, alongside single-use injectors and cytology brushes for procedural use.
These devices are regulated under FDA’s UDI system, with classifications spanning Class I, Class II, and unclassified (U) categories. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Olympus Medical Systems Corporation manufacture?
Olympus Medical Systems Corporation produces a range of endoscopic devices, including both single-use and reusable options. Their portfolio covers non-bioabsorbable polymeric biliary stents, disposable biopsy forceps, single-use sphincterotomes, reusable video colonoscopes, flushing tubing sets, electrical connection cables, injectors, and cytology brushes. These devices are designed for procedural and diagnostic use in endoscopy.
Where is Olympus Medical Systems Corporation based?
Olympus Medical Systems Corporation is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, including FDA compliance for its medical devices.
Which regulatory registries list Olympus Medical Systems Corporation’s devices?
Olympus Medical Systems Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to identify and verify the devices under the company’s portfolio.
How are Olympus Medical Systems Corporation’s devices classified under U.S. regulations?
Olympus Medical Systems Corporation’s devices fall into different regulatory classifications under the FDA: Class I (generally low-risk), Class II (moderate-risk requiring special controls), and unclassified (U) categories. The classification depends on factors like the device’s intended use, risk level, and potential patient exposure, ensuring appropriate oversight and compliance requirements.
Why are some of Olympus Medical Systems Corporation’s devices reusable while others are single-use?
The distinction between reusable and single-use devices depends on their design, risk profile, and clinical application. Reusable devices like video colonoscopes and flushing tubing sets are engineered for repeated sterilization and use, reducing waste and cost. In contrast, single-use items such as disposable biopsy forceps or sphincterotomes minimize infection risks by avoiding reprocessing, aligning with FDA guidelines for patient safety in high-touch or invasive procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
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Catalogue (2911)
Page 1 of 59| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Single Use Biliary Drainage Stent V | PBD-1032-1010 | FDA UDI | Class II | Active |
| Stopper | MAJ-961 | FDA UDI | Class II | Unknown |
| Single Use Biliary Stent V | PBD-202-1005 | FDA UDI | Class II | Unknown |
| Biliary Drainage Tube | PBD-210-1012 | FDA UDI | Class II | Unknown |
| Single Use Injector | NM-400Y-0423 | FDA UDI | Class II | Active |
| Evis Exera Ii Colonovideoscope | CF-Q165L | FDA UDI | Class II | Unknown |
| Single Use Biliary Stent V | PBD-201-1007 | FDA UDI | Class II | Unknown |
| Single Use Biliary Stent V | PBD-200-0705 | FDA UDI | Class II | Unknown |
| Water Filter | MAJ-824 | FDA UDI | Class II | Unknown |
| Single Use Biliary Drainage Stent V | PBD-1031-0813 | FDA UDI | Class II | Active |
| Single Use Biliary Stent V | PBD-202-0807 | FDA UDI | Class II | Unknown |
| Single Use Biliary Drainage Stent V | PBD-1031-0709 | FDA UDI | Class II | Active |
| Tube holder | MAJ-1593 | FDA UDI | Class II | Unknown |
| Single Use Injector | NM-400U-0523 | FDA UDI | Class II | Active |
| Video Coupler | OLYMPUS MH-999E | FDA UDI | Class II | Unknown |
| Disposable Injector Nm | NM-201L-0823 | FDA UDI | Class II | Unknown |
| Gastrointestinal Videoscope | GIF-XP150N | FDA UDI | Class II | Unknown |
| Eyepiece Cap | MB-147 | FDA UDI | Class II | Unknown |
| Papillotomy Knife | KD-20Q-1 | FDA UDI | Class II | Unknown |
| Rhino-Laryngofiberscope | OLYMPUS ENF TYPE GP | FDA UDI | Class II | Active |
| Alcohol Container | MB-264 | FDA UDI | Class II | Unknown |
| Single Use Sphincterotome V(Distal Wireguided) | KD-VC411Q-0720 | FDA UDI | Class II | Active |
| Single Use Injector | NM-400U-0625 | FDA UDI | Class II | Unknown |
| Disposable Biopsy Forceps | FB-230K | FDA UDI | Class I | Active |
| Evis Duodenovideoscope | OLYMPUS JF TYPE 140F | FDA UDI | Class II | Unknown |
| Brush | MH-362 | FDA UDI | U | Active |
| Single Use Preloaded Sphincterotome V | KD-V611M-07301A | FDA UDI | Class II | Active |
| Extension Cable For Rc | MAJ-1931 | FDA UDI | Class II | Unknown |
| Disposable Biopsy Forceps | FB-214U | FDA UDI | Class I | Unknown |
| Grasping Forceps | FG-6L-1 | FDA UDI | Class II | Unknown |
| Evis Exera Colonovideoscope | OLYMPUS CF TYPE Q160ZL | FDA UDI | Class II | Unknown |
| Single Use Rotatable Clip Fixing Device | HX-201LR-135 | FDA UDI | Class II | Unknown |
| Disposable Cytology Brush | BC-202D-1210 | FDA UDI | Class II | Active |
| Visera Video System Autoclavable Camera Head | OTV-S7H-VA | FDA UDI | Class II | Unknown |
| Single Use Rotatable Clip Fixing Device | HX-201YR-135 | FDA UDI | Class II | Active |
| Single Use Biliary Drainage Stent V | PBD-1032-0710 | FDA UDI | Class II | Active |
| Evis Duodenovideoscope | JF-140R | FDA UDI | Class II | Unknown |
| Interface For Esu (vio Series) | MAJ-2249 | FDA UDI | Class II | Active |
| Disposable Distal Attachment | D-201-11804 | FDA UDI | Class II | Active |
| Suction Valve | MD-493 | FDA UDI | Class II | Active |
| Extension Unit For Uces-4 | MAJ-2191 | FDA UDI | Class II | Unknown |
| Auxiliary Water Tube | MB-1 | FDA UDI | Class II | Unknown |
| Disposable Distal Attachment | D-201-10704 | FDA UDI | Class II | Active |
| Single Use Biopsy Forceps | FB-245U | FDA UDI | Class I | Active |
| Single Use Injector | NM-400L-0423 | FDA UDI | Class II | Active |
| High Flow Insufflation Unit | UHI-4 | FDA UDI | Class II | Active |
| Single Use Injector NM600/610 | NM-610U-0623 | FDA UDI | Class II | Active |
| Gastrointestinal Videoscope | GIF-H170 | FDA UDI | Class II | Unknown |
| Papillotomy Knife | KD-19Q-1 | FDA UDI | Class II | Unknown |
| Single Use Preloaded Sphincterotome V | KD-V611M-07201A | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Olympus Medical Systems Corp. HACHIOJI-SHI Tokyo · JP FEI 3002807795