FDA 510(k)

Monik® - 一次性内窥镜套管

K号: K233386 · 2024-05-24

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

决定日期2024-05-24

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Monik™ - Disposable Endoscopic Trocar 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 2024-05-24 under 510(k) number K233386. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Monik™ - Disposable Endoscopic Trocar?

Monik™ - Disposable Endoscopic Trocar is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K233386.

When did Monik™ - Disposable Endoscopic Trocar receive FDA 510(k) clearance?

Monik™ - Disposable Endoscopic Trocar received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233386.

Who is the listed applicant for Monik™ - Disposable Endoscopic Trocar?

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 Monik™ - Disposable Endoscopic Trocar?

The FDA product code for Monik™ - Disposable Endoscopic Trocar is GCJ.

列明M/s. Meril Endo Surgery Private Limited.为申报人的其他记录

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相关器械（代码：GCJ）

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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