FDA 510(k)

Localite TMS Navigator TS

K-Number: K223577 · 2023-04-17

Decision Date2023-04-17

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Localite TMS Navigator TS is the device name listed in this FDA 510(k) record. The listed applicant is Localite GmbH. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K223577. 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 Localite TMS Navigator TS?

Localite TMS Navigator TS is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Localite GmbH. The 510(k) number is K223577.

When did Localite TMS Navigator TS receive FDA 510(k) clearance?

Localite TMS Navigator TS received FDA 510(k) clearance on 2023-04-17, under 510(k) number K223577.

Who is the listed applicant for Localite TMS Navigator TS?

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

What is the FDA product code for Localite TMS Navigator TS?

The FDA product code for Localite TMS Navigator TS is HAW.

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 AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners K250893Ball 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.