Saneso, Inc.

Saneso, Inc. specializes in reusable flexible endoscopic devices. Their primary products include flexible video colonoscopes and gastroscopes, designed for internal imaging of the colon and stomach, respectively. These devices come in single-camera and 360-degree imaging models, with optional advanced imaging features like Select Band Imaging (SBI) and Dual Band Imaging (DBI). They also produce an endoscopic control and video-imaging system, as well as accessories such as the Saneso Lens Wash Bottle Assembly for device maintenance.

Saneso, Inc. is based in the United States. Their devices fall under the US regulatory classification system, specifically as Class II medical devices. This classification indicates moderate risk and requires compliance with applicable US regulations, including those governed by the FDA. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, reflecting their regulatory status.

Saneso, Inc.’s devices are included in the FDA’s official registries, specifically the 510(k) database and the Unique Device Identifier (UDI) system. These registries track medical devices that have undergone the necessary regulatory pathways, such as the 510(k) premarket notification process, to demonstrate substantial equivalence to legally marketed predicate devices. Listing in these databases ensures transparency and compliance with US regulatory requirements.

Saneso, Inc.’s devices are classified as Class II under the US regulatory framework. Class II devices are considered to have moderate risk and typically require special controls in addition to general controls to ensure their safety and effectiveness. This classification applies to reusable flexible video colonoscopes, gastroscopes, and related endoscopic systems, which are used in procedures requiring precise imaging and access to internal body cavities.

Saneso, Inc.’s colonoscopes and gastroscopes incorporate standard video imaging capabilities, with optional advanced imaging features such as Select Band Imaging (SBI) and Dual Band Imaging (DBI). SBI enhances tissue contrast by highlighting specific wavelengths, while DBI provides dual-band imaging for improved visualization of mucosal patterns and vascular structures. These technologies are designed to support better diagnostic accuracy during endoscopic procedures.