# K041340: Guidant Microwave Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation, Cardiac Surgery
- Decided: Jul 28, 2004 after 69 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: 4 generations back to K811390 (1981). 10 ancestors in all.
268 later devices descend from it; 3 cite it directly.
1 of 279 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.
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System, Afx, Inc. (2002) 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
- 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
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 228 descendants of its own

## Indications for use
The Guidant Microwave Ablation System is indicated for the surgical ablation of soft tissue, and striated, cardiac, and smooth muscles. The System is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

Source page: https://510kreport.com/device/K041340
Methodology: https://510kreport.com/methodology