Conductive Silicone Rubber Electrode

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231167

Identifiers

510(k) Number: K231167 FDA 510(k)
FDA Product Code: GXY FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.1320 FDA 510(k)
Regulation Number: 882.1320 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

For the Conductive Silicone Rubber Electrode, a medical device used in neurology for the insertion and retrieval of electrodes during surgical procedures. It features a unique silicone rubber construction that provides excellent conductivity and biocompatibility.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K231167	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Guangzhou Xinbo Electronic Co., Ltd
FDA Applicant: Guangzhou Xinbo Electronic Co., Ltd.

Sources (1)

FDA 510(k) K231167 24 fields · synced Jun 24, 2026