FDA 510(k)

EasyClip Xpress

K号: K162321 · 2017-02-10

决定日期2017-02-10

产品代码JDR

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

EasyClip Xpress is the device name listed in this FDA 510(k) record. The listed applicant is Restore Surgical, LLC Dba Instratek. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K162321. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EasyClip Xpress?

EasyClip Xpress is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Restore Surgical, LLC Dba Instratek. The 510(k) number is K162321.

When did EasyClip Xpress receive FDA 510(k) clearance?

EasyClip Xpress received FDA 510(k) clearance on 2017-02-10, under 510(k) number K162321.

Who is the listed applicant for EasyClip Xpress?

The FDA 510(k) record lists Restore Surgical, LLC Dba Instratek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyClip Xpress?

The FDA product code for EasyClip Xpress is JDR.

列明Restore Surgical, LLC Dba Instratek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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