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FDA 510(k)

Medline Electrocautery Pencil

K-Number: K190643 · 2019-05-06

ApplicantMedline Industries, Inc.
Decision Date2019-05-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Electrocautery Pencil is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-05-06 under approval number K190643. 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 Medline Electrocautery Pencil?

Medline Electrocautery Pencil is a medical device that received FDA 510(k) clearance on 2019-05-06. It is manufactured by Medline Industries, Inc.. The 510(k) number is K190643.

When was Medline Electrocautery Pencil approved by the FDA?

Medline Electrocautery Pencil received FDA 510(k) clearance on 2019-05-06, under approval number K190643.

What company makes Medline Electrocautery Pencil?

Medline Electrocautery Pencil is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Electrocautery Pencil?

The FDA product code for Medline Electrocautery Pencil 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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