FDA 510(k)

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

Numéro K : K213786 · 2022-06-27

DemandeurNingbo Shun YE Medical Company, Ltd.

Date de décision2022-06-27

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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