FDA 510(k)

Reprocessed Endoscopic Trocars and Sleeves

K-번호: K201511 · 2020-07-31

결정일2020-07-31

제품 코드NLM

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Reprocessed Endoscopic Trocars and Sleeves 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 2020-07-31 under 510(k) number K201511. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Reprocessed Endoscopic Trocars and Sleeves?

Reprocessed Endoscopic Trocars and Sleeves is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K201511.

When did Reprocessed Endoscopic Trocars and Sleeves receive FDA 510(k) clearance?

Reprocessed Endoscopic Trocars and Sleeves received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201511.

Who is the listed applicant for Reprocessed Endoscopic Trocars and Sleeves?

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 Endoscopic Trocars and Sleeves?

The FDA product code for Reprocessed Endoscopic Trocars and Sleeves is NLM.

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