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FDA 510(k)

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

K-Number: K201931 · 2021-10-02

ApplicantDixi Medical
Decision Date2021-10-02
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is a medical device manufactured by Dixi Medical. It received FDA 510(k) clearance on 2021-10-02 under approval number K201931. 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 Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is a medical device that received FDA 510(k) clearance on 2021-10-02. It is manufactured by Dixi Medical. The 510(k) number is K201931.

When was Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) approved by the FDA?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) received FDA 510(k) clearance on 2021-10-02, under approval number K201931.

What company makes Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is manufactured by Dixi Medical.

What is the FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

The FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is GYC.

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Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Dixi Medical

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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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