FDA 510(k)

Single Use Rotatable and Repositionable Hemoclip

K-번호: K201771 · 2020-10-19

결정일2020-10-19

제품 코드PKL

자문 위원회GU

결정Substantially Equivalent

기기 요약

Single Use Rotatable and Repositionable Hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K201771. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Single Use Rotatable and Repositionable Hemoclip?

Single Use Rotatable and Repositionable Hemoclip is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K201771.

When did Single Use Rotatable and Repositionable Hemoclip receive FDA 510(k) clearance?

Single Use Rotatable and Repositionable Hemoclip received FDA 510(k) clearance on 2020-10-19, under 510(k) number K201771.

Who is the listed applicant for Single Use Rotatable and Repositionable Hemoclip?

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

What is the FDA product code for Single Use Rotatable and Repositionable Hemoclip?

The FDA product code for Single Use Rotatable and Repositionable Hemoclip is PKL.

Anrei Medical (Hangzhou) Co., Ltd.를 신청인으로 등재한 기타 기록

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