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FDA 510(k)

Minimally Invasive Prostate Surgery Navigation System

K-Number: K221499 · 2022-11-22

ApplicantAugment Intelligent Medical System (China) Co., Ltd.
Decision Date2022-11-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Augment Intelligent Medical System (China) Co., Ltd.. The 510(k) number is K221499.

When was Minimally Invasive Prostate Surgery Navigation System approved by the FDA?

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

What company makes Minimally Invasive Prostate Surgery Navigation System?

Minimally Invasive Prostate Surgery Navigation System is manufactured by Augment Intelligent Medical System (China) Co., Ltd..

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.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Augment Intelligent Medical System (China) Co., Ltd.

K242314Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

Related Devices (Code: LLZ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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