# K041739: Edwards E360 Surgical Ablation Device

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 29, 2004 after 93 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM), Cardiofocus, Inc. (2001) Summary page 1.
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System, Afx, Inc. (2002) Summary page 1.
- K880103: Catheter, Cannula and Tubing, Vascular, Cardiopul., Research Medical, Inc. (1988) Summary page 1.
- K001063: Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7, Baxter Healthcare Corp (2000) Summary page 1.

## Indications for use
The Edwards E360 surgical ablation device is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, and colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece). The Edwards E360 surgical ablation device is indicated for use in medicine and surgery with 980 to 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Cardiac/Thoracic Surgery, Plastic Surgery, and Dermatology.

Source page: https://510kreport.com/device/K041739
Methodology: https://510kreport.com/methodology