meddevicedb.com FDA Device Reference

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)

K243713 Class II Traditional
Decision Date
2025-08-19
Sponsor / Applicant
Agnes Medical Co., Ltd.

Technical Specification

510(k) Submission ID K243713
Product Code GEI
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4400
Decision Date 2025-08-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

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 under submission number K243713, sponsored by Agnes Medical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-08-19.

Classification & Regulation

This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.