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)

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)

K Number

K243713

Device Class

FDA class 2

Clearance Type

Traditional

Regulation Number

878.4400

Medical Specialty

General, Plastic Surgery

Decision

Substantially Equivalent

Statement or Summary

Summary

Applicant

Agnes Medical Co., Ltd.

Date Received

December 2, 2024

Decision Date

August 19, 2025

Product Code

GEI

Advisory Committee

General, Plastic Surgery

Review Advisory Committee

SU

Third Party

N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.