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FDA 510(k)

Neocis Guidance System (NGS) with Yomi Plan v2.0.1

K-Number: K210711 · 2021-12-22

ApplicantNeocis, Inc.
Decision Date2021-12-22
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K210711. 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 Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Neocis, Inc.. The 510(k) number is K210711.

When did Neocis Guidance System (NGS) with Yomi Plan v2.0.1 receive FDA 510(k) clearance?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K210711.

Who is the listed applicant for Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

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

What is the FDA product code for Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

The FDA product code for Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is PLV.

Other records listing Neocis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252376Yomi S Robotic SystemK251835Yomi Robotic SystemK231018Yomi Robotic SystemK222750Yomi Robotic SystemK222049Yomi Robotic SystemK211466Yomi Robotic System with YomiPlan Go

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Related Devices (Code: PLV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252376Yomi S Robotic SystemNeocis, Inc.K251835Yomi Robotic SystemNeocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi Robotic SystemNeocis, Inc.K210947NavidentClaronav, Inc.K211466Yomi Robotic System with YomiPlan GoNeocis, 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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