K243713

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)

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. KR
Product code
GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date
2025-08-19
Date received
2024-12-02
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K243713.pdf

Official FDA record: K243713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.