FDA 510(k)

Rezum Delivery Device, Rezum Generator

K-Number: K190093 · 2019-03-25

ApplicantNxthera (A Boston Scientific Company)

Decision Date2019-03-25

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Rezum Delivery Device, Rezum Generator is the device name listed in this FDA 510(k) record. The listed applicant is Nxthera (A Boston Scientific Company). It received FDA 510(k) clearance on 2019-03-25 under 510(k) number K190093. 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 Delivery Device, Rezum Generator?

Rezum Delivery Device, Rezum Generator is a medical device that received FDA 510(k) clearance on 2019-03-25. The listed applicant is Nxthera (A Boston Scientific Company). The 510(k) number is K190093.

When did Rezum Delivery Device, Rezum Generator receive FDA 510(k) clearance?

Rezum Delivery Device, Rezum Generator received FDA 510(k) clearance on 2019-03-25, under 510(k) number K190093.

Who is the listed applicant for Rezum Delivery Device, Rezum Generator?

The FDA 510(k) record lists Nxthera (A Boston Scientific Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rezum Delivery Device, Rezum Generator?

The FDA product code for Rezum Delivery Device, Rezum Generator is KNS.

Other records listing Nxthera (A Boston Scientific Company) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191505Rezum System

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Official Source

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