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FDA 510(k)

ELECTROSURGICAL ELECTRODE

K-Number: K925116 · 1994-03-01

ApplicantPremier
Decision Date1994-03-01
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Premier. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K925116. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSURGICAL ELECTRODE?

ELECTROSURGICAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Premier. The 510(k) number is K925116.

When did ELECTROSURGICAL ELECTRODE receive FDA 510(k) clearance?

ELECTROSURGICAL ELECTRODE received FDA 510(k) clearance on 1994-03-01, under 510(k) number K925116.

Who is the listed applicant for ELECTROSURGICAL ELECTRODE?

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

What is the FDA product code for ELECTROSURGICAL ELECTRODE?

The FDA product code for ELECTROSURGICAL ELECTRODE is EKZ.

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Related Devices (Code: EKZ)

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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