Seplou (Zhuhai) Co., Ltd.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories2
Latest FDA decision2025-08-26
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | FGB | 2025-08-26 | View |
| 510(k) | K243025 | Ureteral Access Sheath | FED | 2025-01-30 | View |
No matching devices.