Rezum System— 510(k) K262460
Substantially EquivalentBoston Scientific
FDA 510(k) clearance K262460 for Rezum System, Substantially Equivalent on 2026-09-03. Applicant: Boston Scientific. Device class: 2.
Summary
Boston Scientific's Rezum System is filed under KNS, endoscopic electrosurgical units with or without accessories. The record doesn't describe the system beyond its name and that code.
Class II, 21 CFR 876.4300. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Boston Scientific filed from Marlborough, Massachusetts. Review took 48 calendar days (July 17 to September 3, 2026).
Clearance details
- Applicant
- Boston Scientific
- Product code
- Product code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
Source: openFDA MAUDE database, through . 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.