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FDA 510(k)

CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE

K-Number: K850107 · 1985-04-11

Decision Date1985-04-11
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1985-04-11 under 510(k) number K850107. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE?

CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE is a medical device that received FDA 510(k) clearance on 1985-04-11. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K850107.

When did CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE receive FDA 510(k) clearance?

CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE received FDA 510(k) clearance on 1985-04-11, under 510(k) number K850107.

Who is the listed applicant for CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE?

The FDA 510(k) record lists Nicolet Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE?

The FDA product code for CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE is GXZ.

Related Clinical Trials

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.

Other records listing Nicolet Biomedical Instruments as applicant

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.

View all 26 devices →

Related Devices (Code: GXZ)

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.

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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