K243708 is an FDA 510(k) clearance for the Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.), a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on March 27, 2025, 115 days after receiving the submission on December 2, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K243708 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2024 |
| Decision Date | March 27, 2025 |
| Days to Decision | 115 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). |