K250584 is an FDA 510(k) clearance for the Rezum System. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by Boston Scientific Corporation (Marlboro, 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 FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K250584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |