Zhejiang Geyi Medical Instrument Co., Ltd. · Class II · Cleared Dec 16, 2025
| K-number | K252468 |
| Device name | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) |
| Applicant | Zhejiang Geyi Medical Instrument Co., Ltd. |
| Product code | FGB |
| Device class | Class II |
| Decision date | Dec 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Single-use Digital Flexible Ureteroscope (three models: GY-UR9.3, GY-UR8.4, GY-UR7.5) with Endoscope camera system (GY-AIO-121) is designed to visualize the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral access. It can perform diagnostic and therapeutic procedures in the urinary tract using endoscopic accessories.
The proposed device has a 275° active deflection in both directions versus the predicate's 270°. It is available in three models with insertion widths of 3.2 mm and 1.2 mm, and 2.8 mm and 1.1 mm respectively, with smaller outer diameter and larger instrument channel than the predicate. Working length is 670 mm versus the predicate's 650 mm. The device features LED illumination, CMOS image sensor, 160,000 pixel resolution, and active/passive deflection capability.
ISO 8600 series standards, ISO 12233:2017, ISO 15739:2017, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-2-18:2009, IEC 60601-1-2:2020, IEC 62471:2006, ISO 11135:2014, and ASTM standards (F1980-21 and D4169-22).
View the full FDA submission: accessdata.fda.gov