FDA 510(k)

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode

Número K: K231405 · 2024-01-18

RequerenteJiangsu Rong FU Kang Medical Instruments Co., Ltd.

Data da decisão2024-01-18

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K231405. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. The 510(k) number is K231405.

When did Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode receive FDA 510(k) clearance?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode received FDA 510(k) clearance on 2024-01-18, under 510(k) number K231405.

Who is the listed applicant for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

The FDA 510(k) record lists Jiangsu Rong FU Kang Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

The FDA product code for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is GEI.

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