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)

FDA 510(k) K243713 · Agnes Medical Co., Ltd.

510(k) number

K243713

Device name

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)

Applicant

Agnes Medical Co., Ltd.

Product code

GEI

Decision

Substantially Equivalent

Decision date

2025-08-19

Device class

Class 2

Regulation number

878.4400

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery