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FDA 510(k)

Medline Cautery Electrode (SILICONE)

K-Number: K182812 · 2018-12-12

ApplicantMedline Industries, Inc.
Decision Date2018-12-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Cautery Electrode (SILICONE) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-12-12 under 510(k) number K182812. 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 Cautery Electrode (SILICONE)?

Medline Cautery Electrode (SILICONE) is a medical device that received FDA 510(k) clearance on 2018-12-12. The listed applicant is Medline Industries, Inc.. The 510(k) number is K182812.

When did Medline Cautery Electrode (SILICONE) receive FDA 510(k) clearance?

Medline Cautery Electrode (SILICONE) received FDA 510(k) clearance on 2018-12-12, under 510(k) number K182812.

Who is the listed applicant for Medline Cautery Electrode (SILICONE)?

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

What is the FDA product code for Medline Cautery Electrode (SILICONE)?

The FDA product code for Medline Cautery Electrode (SILICONE) is GEI.

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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.

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