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FDA 510(k)

Yomi Robotic System with YomiPlan Go

K-Number: K211466 · 2022-06-14

ApplicantNeocis, Inc.
Decision Date2022-06-14
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Yomi Robotic System with YomiPlan Go is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2022-06-14 under approval number K211466. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yomi Robotic System with YomiPlan Go?

Yomi Robotic System with YomiPlan Go is a medical device that received FDA 510(k) clearance on 2022-06-14. It is manufactured by Neocis, Inc.. The 510(k) number is K211466.

When was Yomi Robotic System with YomiPlan Go approved by the FDA?

Yomi Robotic System with YomiPlan Go received FDA 510(k) clearance on 2022-06-14, under approval number K211466.

What company makes Yomi Robotic System with YomiPlan Go?

Yomi Robotic System with YomiPlan Go is manufactured by Neocis, Inc..

What is the FDA product code for Yomi Robotic System with YomiPlan Go?

The FDA product code for Yomi Robotic System with YomiPlan Go is PLV.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (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 Neocis, Inc.

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Related Devices (Code: PLV)

K161399Neocis Guidance SystemNeocis, Inc. K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)Neocis, Inc.

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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