FDA 510(k)

Single Use Ureteral Access Sheath

K-번호: K220065 · 2022-05-25

신청자Zhejiang Chuangxiang Medical Technology Co., Ltd.

결정일2022-05-25

제품 코드FED

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Single Use Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220065. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Single Use Ureteral Access Sheath?

Single Use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220065.

When did Single Use Ureteral Access Sheath receive FDA 510(k) clearance?

Single Use Ureteral Access Sheath received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220065.

Who is the listed applicant for Single Use Ureteral Access Sheath?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Ureteral Access Sheath?

The FDA product code for Single Use Ureteral Access Sheath is FED.

Zhejiang Chuangxiang Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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