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FDA 510(k)

Disposable Electrosurgical Pencils

K-Number: K170369 · 2018-07-19

ApplicantCathay Manfacturing Corp.
Decision Date2018-07-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Electrosurgical Pencils is the device name listed in this FDA 510(k) record. The listed applicant is Cathay Manfacturing Corp.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) number K170369. 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 Disposable Electrosurgical Pencils?

Disposable Electrosurgical Pencils is a medical device that received FDA 510(k) clearance on 2018-07-19. The listed applicant is Cathay Manfacturing Corp.. The 510(k) number is K170369.

When did Disposable Electrosurgical Pencils receive FDA 510(k) clearance?

Disposable Electrosurgical Pencils received FDA 510(k) clearance on 2018-07-19, under 510(k) number K170369.

Who is the listed applicant for Disposable Electrosurgical Pencils?

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

What is the FDA product code for Disposable Electrosurgical Pencils?

The FDA product code for Disposable Electrosurgical Pencils is GEI.

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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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