510(k) Report

FDA applicant

Afx, Inc.

Fremont, CA2 decisions2001–20020 recalls

FDA records 2 decisions for Afx, Inc. (Fremont, CA) from 2001 to 2002: 2 510(k) clearances. All are in product code NEY (System, Ablation, Microwave And Accessories). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Afx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Afx, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Afx, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Afx, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NEYSystem, Ablation, Microwave And Accessories2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003978Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007Afx, Inc. · 200112cite it
  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 20029cite it

What has FDA decided for it lately?

  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
  • K003978Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007Afx, Inc. · 2001

All 2 as Afx, Inc. →