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FDA 510(k)

EZ-STIK Electrodes

K-Number: K223775 · 2023-01-03

ApplicantSouth Dakota Partners
Decision Date2023-01-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EZ-STIK Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is South Dakota Partners. It received FDA 510(k) clearance on 2023-01-03 under 510(k) number K223775. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-STIK Electrodes?

EZ-STIK Electrodes is a medical device that received FDA 510(k) clearance on 2023-01-03. The listed applicant is South Dakota Partners. The 510(k) number is K223775.

When did EZ-STIK Electrodes receive FDA 510(k) clearance?

EZ-STIK Electrodes received FDA 510(k) clearance on 2023-01-03, under 510(k) number K223775.

Who is the listed applicant for EZ-STIK Electrodes?

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

What is the FDA product code for EZ-STIK Electrodes?

The FDA product code for EZ-STIK Electrodes is GXY.

Related Devices (Code: GXY)

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.

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Official Source

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

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