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FDA 510(k)

CiRX Single use electrosurgical pencil with non-coated and coated electrode

K-Number: K213786 · 2022-06-27

ApplicantNingbo Shun YE Medical Company, Ltd.
Decision Date2022-06-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CiRX Single use electrosurgical pencil with non-coated and coated electrode is a medical device manufactured by Ningbo Shun YE Medical Company, Ltd.. It received FDA 510(k) clearance on 2022-06-27 under approval number K213786. 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 CiRX Single use electrosurgical pencil with non-coated and coated electrode?

CiRX Single use electrosurgical pencil with non-coated and coated electrode is a medical device that received FDA 510(k) clearance on 2022-06-27. It is manufactured by Ningbo Shun YE Medical Company, Ltd.. The 510(k) number is K213786.

When was CiRX Single use electrosurgical pencil with non-coated and coated electrode approved by the FDA?

CiRX Single use electrosurgical pencil with non-coated and coated electrode received FDA 510(k) clearance on 2022-06-27, under approval number K213786.

What company makes CiRX Single use electrosurgical pencil with non-coated and coated electrode?

CiRX Single use electrosurgical pencil with non-coated and coated electrode is manufactured by Ningbo Shun YE Medical Company, Ltd..

What is the FDA product code for CiRX Single use electrosurgical pencil with non-coated and coated electrode?

The FDA product code for CiRX Single use electrosurgical pencil with non-coated and coated electrode 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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