FDA 510(k)

Mirus 结扎夹，Mirus 结扎夹施用器

K号: K200166 · 2020-11-23

申请人M/s. Meril Endo Surgery Private Limited.

决定日期2020-11-23

产品代码FZP

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决定实质等同

器械摘要

Mirus Ligating Clip, Mirus Ligating Clip Applier is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2020-11-23 under 510(k) number K200166. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mirus Ligating Clip, Mirus Ligating Clip Applier?

Mirus Ligating Clip, Mirus Ligating Clip Applier is a medical device that received FDA 510(k) clearance on 2020-11-23. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K200166.

When did Mirus Ligating Clip, Mirus Ligating Clip Applier receive FDA 510(k) clearance?

Mirus Ligating Clip, Mirus Ligating Clip Applier received FDA 510(k) clearance on 2020-11-23, under 510(k) number K200166.

Who is the listed applicant for Mirus Ligating Clip, Mirus Ligating Clip Applier?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mirus Ligating Clip, Mirus Ligating Clip Applier?

The FDA product code for Mirus Ligating Clip, Mirus Ligating Clip Applier is FZP.

列明M/s. Meril Endo Surgery Private 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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官方来源

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