Rezum System— 510(k) K250584

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K250584 for Rezum System, Substantially Equivalent on 2025-06-11. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-27
Decision date: 2025-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.