# K013946: Flex 10 Accessory for the Afx Microwave Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Afx, Inc.
- Decided: Feb 27, 2002 after 90 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K811390 (1981). 9 ancestors in all.
340 later devices descend from it; 9 cite it directly.
1 of 350 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 4.
- K974320: Cryogen Cardiac Cryosurgical System, Cryogen, Inc. (1998) Summary page 4.
- K970496: Heartport Maze System: Cryoprobe Set, Heartport, Inc. (1997) Summary page 4.

## Most influential descendants
- K041340: Guidant Microwave Ablation System (2004), 268 descendants of its own
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 (2005), 231 descendants of its own
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000 (2005), 230 descendants of its own
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 229 descendants of its own

## Indications for use
The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.

Source page: https://510kreport.com/device/K013946
Methodology: https://510kreport.com/methodology