FDA 510(k)

Renasys Edge (66803126)

K号: K223041 · 2022-11-22

决定日期2022-11-22

产品代码OMP

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决定实质等同

器械摘要

Renasys Edge (66803126) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K223041. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Renasys Edge (66803126)?

Renasys Edge (66803126) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K223041.

When did Renasys Edge (66803126) receive FDA 510(k) clearance?

Renasys Edge (66803126) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K223041.

Who is the listed applicant for Renasys Edge (66803126)?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renasys Edge (66803126)?

The FDA product code for Renasys Edge (66803126) is OMP.

列明Smith & Nephew Medical Limited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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