K250917 is an FDA 510(k) clearance for the Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8), a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Shenzhen Sanping Image Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 31, 2025, 218 days after receiving the submission on March 27, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K250917 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 2025 |
| Decision Date | October 31, 2025 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGB — Ureteroscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |