Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Neocis Guidance System (NGS)

K-Number: K191605 · 2019-09-11

ApplicantNeocis, Inc.
Decision Date2019-09-11
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K191605. 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)?

Neocis Guidance System (NGS) is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Neocis, Inc.. The 510(k) number is K191605.

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

Neocis Guidance System (NGS) received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191605.

Who is the listed applicant for Neocis Guidance System (NGS)?

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)?

The FDA product code for Neocis Guidance System (NGS) 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

View all 18 devices →

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.

↑