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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 a medical device manufactured by Cathay Manfacturing Corp.. It received FDA 510(k) clearance on 2018-07-19 under approval 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. It is manufactured by Cathay Manfacturing Corp.. The 510(k) number is K170369.

When was Disposable Electrosurgical Pencils approved by the FDA?

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

What company makes Disposable Electrosurgical Pencils?

Disposable Electrosurgical Pencils is manufactured by Cathay Manfacturing Corp..

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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