K252703 is an FDA 510(k) clearance for the LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500), a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on September 24, 2025, 28 days after receiving the submission on August 27, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K252703 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2025 |
| Decision Date | September 24, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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). |