FDA 510(k)

재처리된 LigaSure 메릴랜드 잇음기/구분기

K-번호: K180499 · 2018-04-23

결정일2018-04-23

제품 코드NUJ

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

결정대체적으로 동일

기기 요약

Reprocessed LigaSure Maryland Jaw Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K180499. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Reprocessed LigaSure Maryland Jaw Sealer/Divider?

Reprocessed LigaSure Maryland Jaw Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K180499.

When did Reprocessed LigaSure Maryland Jaw Sealer/Divider receive FDA 510(k) clearance?

Reprocessed LigaSure Maryland Jaw Sealer/Divider received FDA 510(k) clearance on 2018-04-23, under 510(k) number K180499.

Who is the listed applicant for Reprocessed LigaSure Maryland Jaw Sealer/Divider?

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

What is the FDA product code for Reprocessed LigaSure Maryland Jaw Sealer/Divider?

The FDA product code for Reprocessed LigaSure Maryland Jaw Sealer/Divider is NUJ.

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