# Olympus Medical Systems Corp. (specification developer, HACHIOJI-SHI Tokyo, JP): 20 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Olympus Medical Systems Corp. |
| Owner / operator | Olympus Corporation |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device |
| Location | HACHIOJI-SHI Tokyo, JP |
| New listings | 20 |
| Devices | Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Narrow Band Spectrum; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Hemostatic Metal Clip For The Gi Tract; Bronchoscope (Flexible Or Rigid); Instrument, Ultrasonic Surgical; Electrosurgical, Cutting & Coagulation & Accessories; Laparoscope, General & Plastic Surgery; Transducer, Ultrasonic, Diagnostic |
| Product codes | FET, NWB, FDS, FAS, PKL, EOQ, LFL, GEI, GCJ, ITX, ODG, PSV, KGE |
| Device classes | Class II, Unclassified |
| Medical specialties | Gastroenterology, Urology, Ear, Nose, Throat, General, Plastic Surgery, Radiology |
| Brand names | CH-S700-08-LB; GIF-2T1500; SD-230U-20; D-201-13404; HX-610-135XS; HX-610-135S; HX-610-135; HX-610-090L |
| First new listing | 2026-05-11 |
| Latest new listing | 2026-10-15 |
| FDA registration number | 8010047 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.