Olympus Medical Systems Corp. · Class II · Cleared Sep 19, 2025
| K-number | K251867 |
| Device name | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) |
| Applicant | Olympus Medical Systems Corp. |
| Product code | FDT |
| Device class | Class II |
| Decision date | Sep 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V is a flexible duodenoscope designed for endoscopy and endoscopic surgery within the duodenum. It consists of a flexible insertion section with a CCD chip for image delivery, compatible with Olympus video system centers and light sources, and can accommodate endotherapy accessories such as biopsy forceps through an instrument channel.
The subject device has the same technological characteristics and similar design as the predicate device. The only changes are limited to modifications in reprocessing procedures, specifically in manual cleaning protocols, with minor corresponding labeling updates. There are no changes to indications for use, device design, specifications, or optical or electrical performance.
Not stated in this summary.
The device is substantially equivalent because it has identical indications for use, compatible components, device design, and specifications compared to the predicate device (K250701). The only modifications are to reprocessing procedures for manual cleaning, which were validated through performance testing (bench testing, reprocessing validation, and human factors validation) demonstrating that these changes do not adversely affect device performance, safety, or effectiveness.
View the full FDA submission: accessdata.fda.gov