FDA 510(k)

ShineMed 재충전 가능한 오픈 컷팅 스타일러, ShineMed 구형 인트라루미널 컷팅 스타일러

K-번호: K160969 · 2016-12-12

결정일2016-12-12

제품 코드GDW

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Shinemed, LLC. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K160969. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Shinemed, LLC. The 510(k) number is K160969.

When did ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler receive FDA 510(k) clearance?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler received FDA 510(k) clearance on 2016-12-12, under 510(k) number K160969.

Who is the listed applicant for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

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

What is the FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

The FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is GDW.

관련 기기 (코드: GDW)

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

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GDW)

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