FDA 510(k)

微创前列腺手术导航系统

K号: K221499 · 2022-11-22

申请人Augment Intelligent Medical System (China) Co., Ltd.

决定日期2022-11-22

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Minimally Invasive Prostate Surgery Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Augment Intelligent Medical System (China) Co., Ltd.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221499. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Minimally Invasive Prostate Surgery Navigation System?

Minimally Invasive Prostate Surgery Navigation System is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Augment Intelligent Medical System (China) Co., Ltd.. The 510(k) number is K221499.

When did Minimally Invasive Prostate Surgery Navigation System receive FDA 510(k) clearance?

Minimally Invasive Prostate Surgery Navigation System received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221499.

Who is the listed applicant for Minimally Invasive Prostate Surgery Navigation System?

The FDA 510(k) record lists Augment Intelligent Medical System (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minimally Invasive Prostate Surgery Navigation System?

The FDA product code for Minimally Invasive Prostate Surgery Navigation System is LLZ.

列明Augment Intelligent Medical System (China) Co., Ltd.为申报人的其他记录

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K242314微创前列腺手术导航系统（型号：AmaKris SR1-A-2）

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