FDA 510(k)

Su2ura Approximation Device

K-번호: K201744 · 2021-06-17

결정일2021-06-17

제품 코드OCW

자문 위원회GU

결정Substantially Equivalent

기기 요약

Su2ura Approximation Device is the device name listed in this FDA 510(k) record. The listed applicant is Anchora Medical, Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K201744. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Su2ura Approximation Device?

Su2ura Approximation Device is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Anchora Medical, Ltd.. The 510(k) number is K201744.

When did Su2ura Approximation Device receive FDA 510(k) clearance?

Su2ura Approximation Device received FDA 510(k) clearance on 2021-06-17, under 510(k) number K201744.

Who is the listed applicant for Su2ura Approximation Device?

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

What is the FDA product code for Su2ura Approximation Device?

The FDA product code for Su2ura Approximation Device is OCW.

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Su2ura Approximation Device

기기 요약

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관련 임상시험

관련 기기 (코드: OCW)

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