510(k) · Cleared
ClearedEdwards E360 Surgical Ablation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · GEX Powered Laser Surgical Instrument
Cleared on Sep 29, 2004 as substantially equivalent to K013901 (Cardiofocus, Inc., 2001) and 3 other predicates after a 93-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Sep 29, 2004
- Review
- 93 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K811390 (1981). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
- 3 generations backK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
- 2 generations backK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
- 1 generation backK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
- This deviceK041739 Edwards E360 Surgical Ablation DeviceEdwards Lifesciences, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811390 | CCS100 Cryosurgical System | Frigitronics of Connecticut, Inc. | 1981 | — |
| −3 | K972662 | Cryogen Cryosurgical System | Cryogen, Inc. | 1997 | — |
| −2 | K974320 | Cryogen Cardiac Cryosurgical System | Cryogen, Inc. | 1998 | — |
| −1 | K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | Afx, Inc. | 2002 | — |
| 0 (this device) | K041739 | Edwards E360 Surgical Ablation Device | Edwards Lifesciences, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Summary page 1…Name: Class II, Laser Surgical Instrument Predicate Device(s): Malleable Surgical Lightstic 180 (Marketed under the trade name of Edwards surgical ablation handpiece) (K013901) AFx FLEX 10 Accessory for the AFx Microwave Ablation System (K013946) Edwards Retrograde Cardioplegia Cannula (K880103) Edwar… | 2001 |
| * | K013946 | Flex 10 Accessory for the Afx Microwave Ablation SystemSummary page 1…le Surgical Lightstic 180 (Marketed under the trade name of Edwards surgical ablation handpiece) (K013901) AFx FLEX 10 Accessory for the AFx Microwave Ablation System (K013946) Edwards Retrograde Cardioplegia Cannula (K880103) Edwards Swan-Ganz™ Synthetic ControlCath Thermodilution Catheter (K001063)… | 2002 |
| * | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul.Summary page 1…name of Edwards surgical ablation handpiece) (K013901) AFx FLEX 10 Accessory for the AFx Microwave Ablation System (K013946) Edwards Retrograde Cardioplegia Cannula (K880103) Edwards Swan-Ganz™ Synthetic ControlCath Thermodilution Catheter (K001063) Device Description: The Edwards E360 surgical ablat… | 1988 |
| * | K001063 | Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7…Summary page 1…ory for the AFx Microwave Ablation System (K013946) Edwards Retrograde Cardioplegia Cannula (K880103) Edwards Swan-Ganz™ Synthetic ControlCath Thermodilution Catheter (K001063) Device Description: The Edwards E360 surgical ablation device is a sterile, single-use, disposable device for delivery of 980 n… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 16 ancestors has a recall.
- 3 other devices also cite its predicate K013901.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041739 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041739: Edwards E360 Surgical Ablation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041739
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026