FDA 510(k)

再处理的Ethicon无刀套管；再处理的Ethicon通用套管袖套

K号: K172097 · 2017-10-06

决定日期2017-10-06

产品代码NLM

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决定实质等同

器械摘要

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Renovo, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172097. 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 Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves?

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Renovo, Inc.. The 510(k) number is K172097.

When did Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves receive FDA 510(k) clearance?

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172097.

Who is the listed applicant for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves?

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

What is the FDA product code for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves?

The FDA product code for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves is NLM.

列明Renovo, Inc.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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官方来源

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