FDA 510(k)

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes

Numéro K : K221743 · 2023-09-07

DemandeurJiangsu Bonss Medical Technology Co., Ltd.

Date de décision2023-09-07

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Bonss Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K221743. 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 Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Jiangsu Bonss Medical Technology Co., Ltd.. The 510(k) number is K221743.

When did Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes receive FDA 510(k) clearance?

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes received FDA 510(k) clearance on 2023-09-07, under 510(k) number K221743.

Who is the listed applicant for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

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

What is the FDA product code for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

The FDA product code for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is GEI.

Essais cliniques associés

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Source officielle

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