FDA 510(k)

再处理的内窥镜套管和袖套

K号: K201511 · 2020-07-31

决定日期2020-07-31

产品代码NLM

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决定实质等同

器械摘要

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.

常见问题

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.

列明Stryker Sustainability Solutions为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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