Dongguan Zsr Biomedical Technology Company Limited · Class II · Cleared Feb 11, 2025
| K-number | K243155 |
| Device name | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) |
| Applicant | Dongguan Zsr Biomedical Technology Company Limited |
| Product code | FGB |
| Device class | Class II |
| Decision date | Feb 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
This is a single-use digital flexible ureteroscope system consisting of four ureteroscope models (ZSR-URS-01 through ZSR-URS-04) and an electronic endoscope imaging processor (ZSR-EOS10). The system is used in medical institutions to examine, diagnose, and treat urinary system diseases in adults by providing real-time video imaging of the urinary tract during endoscopic procedures.
The proposed device uses CMOS digital video technology with LED illumination and is sterilized by ethylene oxide (EO), identical to the predicate. It has a flexible scope design with 120°±10° field of view, 0° direction of view, bending angles up to 275° in both directions, and working length of 670mm (±10%). The main differences are minor dimensional variations: insertion portion width of 2.50–2.85mm (vs. predicate 3.15–3.25mm) and slightly narrower specifications overall, all meeting applicable performance standards.
Performance testing per ISO16926-6:2014, ISO 8600-1/4/5:2015/2020, IEC 62471:2006, ISO 12233:2017, ISO 15739:2017, and ISO/CIE 11664-4. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic, pyrogenicity). Sterility and shelf-life per ISO 11135:2014, ISO 11737-1/2:2018/2019, ISO 10993-7:2008, ASTM F1980-2016, ASTM F88/F88M-15, and ASTM D4169-23e1.
The proposed device has identical indications for use (imaging in examination, diagnosis, or treatment of urinary system diseases), same classification, product code, and regulatory pathway as the predicate K230200. Both are single-use flexible ureteroscopes using the same materials, sterilization method, and optical technology. Although the proposed device has slightly smaller dimensional specifications, all performance testing met applicable standards, and these differences do not raise safety or effectiveness concerns. The manufacturer demonstrated substantial equivalence through comprehensive performance and biocompatibility testing without clinical data.
View the full FDA submission: accessdata.fda.gov