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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 the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. It received FDA 510(k) clearance on 2022-06-27 under 510(k) 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. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. The 510(k) number is K213786.

When did CiRX Single use electrosurgical pencil with non-coated and coated electrode receive FDA 510(k) clearance?

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

Who is the listed applicant for CiRX Single use electrosurgical pencil with non-coated and coated electrode?

The FDA 510(k) record lists Ningbo Shun YE Medical Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06358391To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.RECRUITING

Other records listing Ningbo Shun YE Medical Company, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210256CiRx (R) Surgical Mask

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Official Source

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