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FDA 510(k)

REGULUS NAVIGATOR

K-Number: K964229 · 1997-08-19

ApplicantCompass Intl., Inc.
Decision Date1997-08-19
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REGULUS NAVIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Compass Intl., Inc.. It received FDA 510(k) clearance on 1997-08-19 under 510(k) number K964229. 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 REGULUS NAVIGATOR?

REGULUS NAVIGATOR is a medical device that received FDA 510(k) clearance on 1997-08-19. The listed applicant is Compass Intl., Inc.. The 510(k) number is K964229.

When did REGULUS NAVIGATOR receive FDA 510(k) clearance?

REGULUS NAVIGATOR received FDA 510(k) clearance on 1997-08-19, under 510(k) number K964229.

Who is the listed applicant for REGULUS NAVIGATOR?

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

What is the FDA product code for REGULUS NAVIGATOR?

The FDA product code for REGULUS NAVIGATOR is HAW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Compass Intl., 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.

K935456REGULUS MEASUREMENT UNIT

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.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 Partners

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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