FDA 510(k)

DANNIK 一次性单极腹腔镜器械

K号: K201063 · 2020-06-09

申请人Dannik

决定日期2020-06-09

产品代码GEI

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决定实质等同

器械摘要

DANNIK Disposable Monopolar Laparoscopic Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K201063. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DANNIK Disposable Monopolar Laparoscopic Instrument?

DANNIK Disposable Monopolar Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Dannik. The 510(k) number is K201063.

When did DANNIK Disposable Monopolar Laparoscopic Instrument receive FDA 510(k) clearance?

DANNIK Disposable Monopolar Laparoscopic Instrument received FDA 510(k) clearance on 2020-06-09, under 510(k) number K201063.

Who is the listed applicant for DANNIK Disposable Monopolar Laparoscopic Instrument?

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

What is the FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument?

The FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument is GEI.

列明Dannik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。

K200053DANNIK 标本采集系统带部署机构，DANNIK 标本采集系统（仅袋）K193019DANNIK 一次性单极腹腔镜器械 K192711Dannik钛夹 K192643Dannik腹腔镜吸引冲洗系统

相关器械（代码：GEI）

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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