Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM

K-Number: K110010 · 2011-02-09

ApplicantBlackrock Microsystems, Inc.
Decision Date2011-02-09
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Blackrock Microsystems, Inc.. It received FDA 510(k) clearance on 2011-02-09 under 510(k) number K110010. 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 NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM?

NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-09. The listed applicant is Blackrock Microsystems, Inc.. The 510(k) number is K110010.

When did NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM receive FDA 510(k) clearance?

NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM received FDA 510(k) clearance on 2011-02-09, under 510(k) number K110010.

Who is the listed applicant for NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM?

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

What is the FDA product code for NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM?

The FDA product code for NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM 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

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

View on FDA Database →

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

↑