FDA 510(k)

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Número K: K243713 · 2025-08-19

Data da decisão2025-08-19

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) is the device name listed in this FDA 510(k) record. The listed applicant is Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K243713. 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 Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Agnes Medical Co., Ltd.. The 510(k) number is K243713.

When did Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) receive FDA 510(k) clearance?

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K243713.

Who is the listed applicant for Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

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

What is the FDA product code for Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

The FDA product code for Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) is GEI.

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Fonte oficial

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