Rezum System
K-Number: K191505 · 2019-08-02
Decision Date2019-08-02
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Rezum System is a medical device manufactured by Nxthera (A Boston Scientific Company). It received FDA 510(k) clearance on 2019-08-02 under approval number K191505. 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 2019-08-02. It is manufactured by Nxthera (A Boston Scientific Company). The 510(k) number is K191505.
When was Rezum System approved by the FDA?
Rezum System received FDA 510(k) clearance on 2019-08-02, under approval number K191505.
What company makes Rezum System?
Rezum System is manufactured by Nxthera (A Boston Scientific Company).
What is the FDA product code for Rezum System?
The FDA product code for Rezum System is KNS.
Other Devices by Nxthera (A Boston Scientific Company)
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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.