510(k) · Cleared
ClearedNcontact Coagulation System Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ncontact Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 1, 2006 as substantially equivalent to K031247 (Medtronic Vascular, 2003) and 3 other predicates after a 94-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Dec 1, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K942299 (1995). 53 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 5 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 4 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 3 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 2 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 1 generation backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- This deviceK062539 Ncontact Coagulation System KitNcontact Surgical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −6 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −5 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −4 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −3 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −1 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| 0 (this device) | K062539 | Ncontact Coagulation System Kit | Ncontact Surgical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation SystemSummary page 1…1. Medtronic, Inc., Cardioblate Bipolar Radiofrequency Ablation System (K031247) 2. Arthrocare, Corporation Electro… | 2003 |
| * | K992972 | Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare…Summary page 1…(K031247) 2. Arthrocare, Corporation Electrosurgery System (K992972) 3. Arthrocare, Corporation Electro… | 1999 |
| * | K971532 | Arthrocare Electrosurgery SystemSummary page 1…osurgery System (K992972) 3. Arthrocare, Corporation Electrosurgery System (K971532) 4. Boston Scientific, Electrosurgical… | 1997 |
| * | K981981 | Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt)…Summary page 1…ectrosurgery System (K971532) 4. Boston Scientific, Electrosurgical System (K981981) Section 5 - Summary Page 5-1 of 5-2 nContact Surgical, Inc. Coagulation System 510k Submission Traditional P… | 1998 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 53 ancestors have a recall of any class.
- 3 other devices also cite its predicate K031247.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The nContact Coagulation System is intended for the coagulation of soft tissue using Radiofrequency (RF) energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062539: Ncontact Coagulation System Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062539
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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