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FDA 510(k)

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

K-Number: K211954 · 2022-11-10

ApplicantSpes Medica Srl
Decision Date2022-11-10
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is a medical device manufactured by Spes Medica Srl. It received FDA 510(k) clearance on 2022-11-10 under approval number K211954. 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 Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Spes Medica Srl. The 510(k) number is K211954.

When was Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid approved by the FDA?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid received FDA 510(k) clearance on 2022-11-10, under approval number K211954.

What company makes Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is manufactured by Spes Medica Srl.

What is the FDA product code for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

The FDA product code for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is GYC.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT05623306 SEEG-Guided DBS for OCD RECRUITING NCT03873259 Intraoperative Assessment of of Burst Wave Lithotripsy (BWL) RECRUITING NCT04816591 Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA COMPLETED NCT07563257 Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation NOT_YET_RECRUITING NCT07556692 A Study of Home-use Brain Stimulation to Treat Bipolar Depression RECRUITING

Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026)

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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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