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FDA 510(k)

NeuGuide

K-Number: K160569 · 2016-07-06

ApplicantPop Medical Solutions
Decision Date2016-07-06
Product CodePBQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NeuGuide is the device name listed in this FDA 510(k) record. The listed applicant is Pop Medical Solutions. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K160569. The device is classified under product code PBQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuGuide?

NeuGuide is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Pop Medical Solutions. The 510(k) number is K160569.

When did NeuGuide receive FDA 510(k) clearance?

NeuGuide received FDA 510(k) clearance on 2016-07-06, under 510(k) number K160569.

Who is the listed applicant for NeuGuide?

The FDA 510(k) record lists Pop Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuGuide?

The FDA product code for NeuGuide is PBQ.

Related Devices (Code: PBQ)

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.

K260380MenditEscala Medical, Ltd.K230730ApyxEscala MedicalK220420Saffron Fixation SystemColoplast A/SK213783ApyxEscala Medical

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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