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Single Use RF Surgical Electrode - AN-W3B

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243713

by Agnes Medical Co., Ltd.

Identifiers

510(k) Number
K243713 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
Models / Variants
AN-B FDA 510(k)
AN-C FDA 510(k)
AN-E FDA 510(k)
AN-I FDA 510(k)
AN-S FDA 510(k)
AN-W3A FDA 510(k)
AN-F3A FDA 510(k)
AN-IL FDA 510(k)
AN-SL FDA 510(k)
AN-W3B FDA 510(k)
AN-F1A FDA 510(k)
AN-F3B FDA 510(k)
AN-B3A FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Single Use RF Surgical Electrode - AN-W3B by Agnes Medical Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 13 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Agnes Medical Co., Ltd.

Sources (1)

  • FDA 510(k) K243713 24 fields · synced Jun 18, 2026