Olympus Medical Systems Corp. - FDA 510(k) Cleared Devices

Olympus Medical Systems Corp., is a global medical device manufacturer headquartered in Hachiochi-Shi, Japan. The company specializes in endoscopic imaging systems and therapeutic devices for minimally invasive procedures.

Olympus has received 103 FDA 510(k) clearances from 103 total submissions since 2012. The company's regulatory portfolio is dominated by Gastroenterology & Urology devices, including endoscopes, hemostatic forceps, biopsy instruments, and sphincterotomes. The latest clearance in 2026 reflects continued active development and market engagement.

Recent cleared devices include advanced videoscope systems, single-use endotherapy accessories, and specialized visualization platforms for gastrointestinal and bronchial procedures. These products support diagnostic and therapeutic applications across multiple clinical specialties.

Explore the complete list of device names, product codes, and individual clearance dates in the database to review Olympus Medical Systems' full regulatory history.

Regulatory submissions have been managed by Olympus Corporation of the Americas, Gyrus Acmi, Inc. and Olympus Surgical Technologies America.