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FDA 510(k)

NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY

K-Number: K993622 · 2000-01-24

ApplicantAlpha Omega , Ltd.
Decision Date2000-01-24
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY 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 2000-01-24 under 510(k) number K993622. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY?

NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY is a medical device that received FDA 510(k) clearance on 2000-01-24. The listed applicant is Alpha Omega , Ltd.. The 510(k) number is K993622.

When did NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY receive FDA 510(k) clearance?

NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY received FDA 510(k) clearance on 2000-01-24, under 510(k) number K993622.

Who is the listed applicant for NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY?

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 NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY?

The FDA product code for NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY is GZL.

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 SYSTEMK013396ALPHA DRIVE SYSTEM

Related Devices (Code: GZL)

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.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.

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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