FDA 510(k)

vesair 콘시스코피ック 셔츠

K-번호: K162356 · 2017-03-02

결정일2017-03-02

제품 코드KNY

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Vesair Cystoscopic Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Solace Therapeutics. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K162356. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vesair Cystoscopic Sheath?

Vesair Cystoscopic Sheath is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Solace Therapeutics. The 510(k) number is K162356.

When did Vesair Cystoscopic Sheath receive FDA 510(k) clearance?

Vesair Cystoscopic Sheath received FDA 510(k) clearance on 2017-03-02, under 510(k) number K162356.

Who is the listed applicant for Vesair Cystoscopic Sheath?

The FDA 510(k) record lists Solace Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vesair Cystoscopic Sheath?

The FDA product code for Vesair Cystoscopic Sheath is KNY.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

vesair 콘시스코피ック 셔츠

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KNY)

공식 출처