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FDA 510(k)

PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES

K-Number: K052875 · 2005-12-27

ApplicantSummit Manufacturing, LLC
Decision Date2005-12-27
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Summit Manufacturing, LLC. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K052875. 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 PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES?

PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Summit Manufacturing, LLC. The 510(k) number is K052875.

When did PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES receive FDA 510(k) clearance?

PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES received FDA 510(k) clearance on 2005-12-27, under 510(k) number K052875.

Who is the listed applicant for PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES?

The FDA 510(k) record lists Summit Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES?

The FDA product code for PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES is GXY.

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Related Devices (Code: GXY)

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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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