FDA 510(k)

Rezum 전달 장치, Rezum 제너레이터

K-번호: K190093 · 2019-03-25

신청자Nxthera (A Boston Scientific Company)

결정일2019-03-25

제품 코드KNS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Nxthera (A Boston Scientific Company)를 신청인으로 등재한 기타 기록

K191505리즈름 시스템

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