FDA 510(k)

AURAGEN CORTICAL SURFACE ELECTRODES

K-Number: K082250 · 2008-10-10

Decision Date2008-10-10

Product CodeGYC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AURAGEN CORTICAL SURFACE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurosciences. It received FDA 510(k) clearance on 2008-10-10 under 510(k) number K082250. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAGEN CORTICAL SURFACE ELECTRODES?

AURAGEN CORTICAL SURFACE ELECTRODES is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Integra Neurosciences. The 510(k) number is K082250.

When did AURAGEN CORTICAL SURFACE ELECTRODES receive FDA 510(k) clearance?

AURAGEN CORTICAL SURFACE ELECTRODES received FDA 510(k) clearance on 2008-10-10, under 510(k) number K082250.

Who is the listed applicant for AURAGEN CORTICAL SURFACE ELECTRODES?

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

What is the FDA product code for AURAGEN CORTICAL SURFACE ELECTRODES?

The FDA product code for AURAGEN CORTICAL SURFACE ELECTRODES is GYC.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Integra Neurosciences as applicant

K050720NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 K031086CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 K022554MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM K022553CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L K020558LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE

View all 8 devices →

Related Devices (Code: GYC)

K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K221123WISE Cortical Strip (WCS)Wise S.R.L.K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica Srl K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems

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.