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AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND - P

by Afx, Inc.

510(k) K003978

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003978 Date22 May 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NEY
Models / Variants
P
P
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Afx Microwave Generator is a system for ablation procedures, including the Flex Ablation Wand and Lynx Ablation Wand components. This device is designed for use in medical procedures requiring tissue ablation through microwave energy. The system includes multiple model numbers and is intended for use in general and plastic surgery applications.

The device is supplied as part of a system that includes the microwave generator and specific ablation wand models. It is a Class II medical device that has received FDA 510(k) clearance with the K number K003978. The device is not described as single-use or reusable in the provided data, and no specific information regarding sterility, MRI safety, or storage conditions is included in the specifications.

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