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FDA 510(k)

ALPHA DRIVE SYSTEM

K-Number: K013396 · 2002-08-07

ApplicantAlpha Omega , Ltd.
Decision Date2002-08-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALPHA DRIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega , Ltd.. It received FDA 510(k) clearance on 2002-08-07 under 510(k) number K013396. 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 ALPHA DRIVE SYSTEM?

ALPHA DRIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-07. The listed applicant is Alpha Omega , Ltd.. The 510(k) number is K013396.

When did ALPHA DRIVE SYSTEM receive FDA 510(k) clearance?

ALPHA DRIVE SYSTEM received FDA 510(k) clearance on 2002-08-07, under 510(k) number K013396.

Who is the listed applicant for ALPHA DRIVE SYSTEM?

The FDA 510(k) record lists Alpha Omega , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA DRIVE SYSTEM?

The FDA product code for ALPHA DRIVE SYSTEM 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 Alpha Omega , Ltd. 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.

K071697NEURONAV SYSTEM AND NEURONAV DRIVEK051830NEURODRIVE SYSTEMK993622NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY

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

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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