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FDA 510(k)

Rezum System

K-Number: K250584 · 2025-06-11

ApplicantBoston Scientific Corporation
Decision Date2025-06-11
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rezum System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-06-11 under approval number K250584. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rezum System?

Rezum System is a medical device that received FDA 510(k) clearance on 2025-06-11. It is manufactured by Boston Scientific Corporation. The 510(k) number is K250584.

When was Rezum System approved by the FDA?

Rezum System received FDA 510(k) clearance on 2025-06-11, under approval number K250584.

What company makes Rezum System?

Rezum System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Rezum System?

The FDA product code for Rezum System is KNS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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