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FDA 510(k)

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

K-Number: K163442 · 2017-09-28

ApplicantModern Medical Equipment Manufacturing Limited
Decision Date2017-09-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is a medical device manufactured by Modern Medical Equipment Manufacturing Limited. It received FDA 510(k) clearance on 2017-09-28 under approval number K163442. 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 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is a medical device that received FDA 510(k) clearance on 2017-09-28. It is manufactured by Modern Medical Equipment Manufacturing Limited. The 510(k) number is K163442.

When was Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) approved by the FDA?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) received FDA 510(k) clearance on 2017-09-28, under approval number K163442.

What company makes Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is manufactured by Modern Medical Equipment Manufacturing Limited.

What is the FDA product code for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

The FDA product code for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is GEI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026)

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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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