K250584
- 510(k) number
- K250584
- Device name
- Rezum System
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2025-06-11
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250584.pdf
Official FDA record: K250584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.