K243713
- 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.