Opcom Medical, Inc. - FDA 510(k) Cleared Devices

Opcom Medical, Inc. is a subsidiary of OPCOM Group, established in 2022 with a manufacturing facility in New Taipei City, Taiwan. The company specializes in OEM, ODM, and OBM of disposable endoscopes and catheter solutions. OMI provides comprehensive design, R&D, verification, certification, and mass production services backed by over 20 years of industry experience.

Opcom Medical has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus is Gastroenterology & Urology devices. The latest clearance was issued in 2025, reflecting active ongoing development and market engagement.

The company's product portfolio includes flexible ureteroscopes, bronchoscopes, cystoscopes, and choledochoscopes. OMI also manufactures camera modules, catheter components, and endoscope camera control units. Advanced manufacturing capabilities include laser welding, thermal bonding, micro injection molding, and precision tubing assembly.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.