Data / Medical devices / Endoscopic Access Overtube, Gastroenterology-Urology / Japan
FDA-registered makers of Endoscopic Access Overtube, Gastroenterology-Urology in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Endoscopic Access Overtube, Gastroenterology-Urology (product code FED). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Endoscopic Access Overtube, Gastroenterology-Urology
- Product code
- FED
- Country
- Japan
Makers of Endoscopic Access Overtube, Gastroenterology-Urology in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Complaint file establishment, Specification developer | 3 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 3 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant | Shirakawa Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJI SYSTEMS CORPORATION, Shirakawa Plant | Nishi Shirakawa Gun Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.