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FDA 510(k)

Neocis Guidance System

K-Number: K161399 · 2016-12-22

ApplicantNeocis, Inc.
Decision Date2016-12-22
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K161399. 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?

Neocis Guidance System is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Neocis, Inc.. The 510(k) number is K161399.

When did Neocis Guidance System receive FDA 510(k) clearance?

Neocis Guidance System received FDA 510(k) clearance on 2016-12-22, under 510(k) number K161399.

Who is the listed applicant for Neocis Guidance System?

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?

The FDA product code for Neocis Guidance System is PLV.

Other records listing Neocis, Inc. as applicant

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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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