FDA 510(k) clearance · back to tracker

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)

Agnes Medical Co., Ltd. cleared K243713 on 2025-08-19, decision: substantially equivalent

K-number

K243713

Sponsor

Agnes Medical Co., Ltd.

Device

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)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-08-19

Product code

GEI

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K243713on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.