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FDA 510(k)

Neural Navigator

K-Number: K191422 · 2020-04-06

ApplicantSoterix Medical, Inc.
Decision Date2020-04-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neural Navigator is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K191422. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neural Navigator?

Neural Navigator is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K191422.

When did Neural Navigator receive FDA 510(k) clearance?

Neural Navigator received FDA 510(k) clearance on 2020-04-06, under 510(k) number K191422.

Who is the listed applicant for Neural Navigator?

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

What is the FDA product code for Neural Navigator?

The FDA product code for Neural Navigator is HAW.

Other records listing Soterix Medical, 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.

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Related Devices (Code: HAW)

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.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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