FDA 510(k)

NEEDLE ELCTRODE

K-Number: K944265 · 1995-05-05

Decision Date1995-05-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NEEDLE ELCTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Unimed Surgical Products, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K944265. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE ELCTRODE?

NEEDLE ELCTRODE is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Unimed Surgical Products, Inc.. The 510(k) number is K944265.

When did NEEDLE ELCTRODE receive FDA 510(k) clearance?

NEEDLE ELCTRODE received FDA 510(k) clearance on 1995-05-05, under 510(k) number K944265.

Who is the listed applicant for NEEDLE ELCTRODE?

The FDA 510(k) record lists Unimed Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE ELCTRODE?

The FDA product code for NEEDLE ELCTRODE is GEI.

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Other records listing Unimed Surgical Products, Inc. as applicant

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Official Source

View on FDA Database →

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