K250584 is an FDA 510(k) clearance for the Rezum System, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on June 11, 2025, 104 days after receiving the submission on February 27, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K250584 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 27, 2025 |
| Decision Date | June 11, 2025 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |