Olympus Corp. - FDA 510(k) Cleared Devices

Olympus Corp., is a Japanese optics and imaging manufacturer founded in 1919. The company operates from McHenry, US, and holds approximately 70 percent of the global endoscope market.

Olympus has received 140 FDA 510(k) clearances from 142 total submissions between 1978 and 1995. The company's cleared devices span gastroenterology, urology, obstetrics, gynecology, and chemistry specialties. This regulatory record reflects the company's historical focus on endoscopic surgical instruments and related technologies.

Notable cleared device categories include resection electrodes, fiberscopes, stents, sclerotherapy balloons, and chemistry reagents. These products represent core surgical and diagnostic technologies developed across multiple medical specialties.

This company profile is maintained as a historical regulatory record. No FDA 510(k) clearances have been issued since 1995. Explore the complete device clearance history, product codes, and submission dates in the database.