Data / Medical devices / Laparoscope, General & Plastic Surgery / Japan
FDA-registered makers of Laparoscope, General & Plastic Surgery in Japan: 14 establishments
14 establishments in Japan are registered with the FDA to make Laparoscope, General & Plastic Surgery (product code GCJ). 12 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
- Laparoscope, General & Plastic Surgery
- Product code
- GCJ
- Country
- Japan
Makers of Laparoscope, General & Plastic Surgery in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Exporter to the US, Specification developer | 10 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sony Corporation | Yokohama-shi Kanagawa, Japan | Complaint file establishment, Specification developer | 6 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 5 | April 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Contract manufacturer, Manufacturer | 3 | December 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 3 | December 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Eizo Corporation | HAKUSAN Ishikawa, Japan | Manufacturer | 2 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 2 | June 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Mitaka Kohki Co., Ltd. | MITAKA SHI Tokyo, Japan | Contract manufacturer, Manufacturer | 2 | July 6, 2009 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 1 | January 30, 2002 | 0 | 0 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 1 | January 30, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 1 | April 29, 1993 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 1 | March 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Fibertech Co., Ltd. | Sakura-shi Chiba, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sony Global Manufacturing & Operations Corporation Kohda Site | Nukata-gun Aichi, Japan | Contract 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.