510(k) Report

510(k) · Cleared

Cleared

Ncontact Coagulation System Kit, Model CSK

K063012510(k) TraditionalCleared Dec 1, 200660-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ncontact Surgical, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Cleared on Dec 1, 2006 as substantially equivalent to K013392 (Medtronic Vascular, 2002) and 2 other predicates after a 60-day review. Its family tree reaches back 4 generations to 1992. 6 later devices descend from it.

Decided
Dec 1, 2006
Review
60 days
Class
Class II
Product code
OCL
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K921884 (1992). 10 ancestors in all, the oldest K870705 (1987). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 4 other ancestors1987: 1 other ancestor2007: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant clearedK921884 · FORCE 2 · Valleylab, Inc. · 1992K013392 · Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 · Medtronic Vascular · 2002 · recalledK013873 · Cobra Cardiac Electrosurgical System · Boston Scientific Corp · 2002K053326 · Estech Cobra Electrosurgical Unit & Cable · Endoscopic Technologies, Inc. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K053326 · Estech Cobra Electrosurgical Unit & Cable · Endoscopic Technologies, Inc. · 2006K013873 · Cobra Cardiac Electrosurgical System · Boston Scientific Corp · 2002K013392 · Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 · Medtronic Vascular · 2002 · recalledK921884 · FORCE 2 · Valleylab, Inc. · 19920+5
  1. Root · 4 generations backK921884 FORCE 2Valleylab, Inc. · 1992
  2. 3 generations backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
  3. 2 generations backK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
  4. 1 generation backK053326 Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc. · 2006
  5. This deviceK063012 Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006
  6. Descendant · cites it directly · 4 of its ownK082203 Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022…Ncontact Surgical, Inc. · 2008
  7. Descendant · cites it directly · 4 of its ownK071819 Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and…Ncontact Surgical, Inc. · 2007
  8. Descendant · 2 generations on · 3 of its ownK090202 Numeris Guided Coagulation System with Visitrax, Models CSK-121…Ncontact Surgical, Inc. · 2009
  9. Descendant · 3 generations on · 2 of its ownK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
  10. Descendant · 4 generations on · 1 of its ownK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12012: 12014: 12019: 1
2007high 1 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc. · 2008 · cites it directly4descendants
  • K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc. · 2007 · cites it directly4descendants
  • K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc. · 2009 · 2 generations on3descendants
  • K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012 · 3 generations on2descendants
  • K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921884FORCE 2Valleylab, Inc.1992—
−3K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021
−2K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp2002—
−1K053326Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc.2006—
0 (this device)K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc.2006—
+1K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023…Ncontact Surgical, Inc.2008—
+1K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc.2007—
+2K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123…Ncontact Surgical, Inc.2009—
+3K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.2012—
+4K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20141

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
200140
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201210
201410
201910
FIG. 1 — Lineage of K063012, 1992–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OCL? 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 OCL device

  1. #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021
*K041599Cobra Adhere Surgical System
Summary page 1
…2. Endoscopic Technologies, Estech Cobra Adhere Surgical System (K041599, K053326) Section 5 -Summary Page 5-1 of 5-2 nContact Surgical, Inc. Coagulation System 510k Submission Tra…
Estech, Inc.2004—
*K053326Estech Cobra Electrosurgical Unit & Cable
Summary page 1
…2. Endoscopic Technologies, Estech Cobra Adhere Surgical System (K041599, K053326) Section 5 -Summary Page 5-1 of 5-2 nContact Surgical, Inc. Coagulation System 510k Submission Traditional…
Endoscopic Technologies, Inc.2006—

Also cleared against K013392: 11 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc.20084
K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc.20074

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 14 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K082203 (Ncontact Surgical, Inc., 2008) has gone furthest, with 4 descendants of its own.
  • 11 other devices also cite its predicate K013392.

How does its category compare?

All OCL devices

OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCL

1in 2025

2007: 32008: 52009: 22010: 22011: 22012: 62013: 22014: 12017: 12018: 22019: 62020: 12021: 22022: 22024: 12025: 1
2007high 6 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCL

85in 2019

2007: 139 days median2008: 81 days median2012: 75 days median2019: 85 days median
2007high 139 (2007) · low 75 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCL

1in 2021

2008: 12009: 12010: 22013: 12016: 12019: 42020: 42021: 1
2007high 4 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCL

46in 2025

2009: 82010: 232011: 212012: 212013: 132014: 152015: 312016: 762017: 552018: 612019: 492020: 372021: 632022: 592023: 992024: 592025: 46
2007high 99 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007313900
200858110
20092—18
20102—223
20112—021
2012675021
20132—113
20141—015
20150—031
20160—176
20171—055
20182—061
2019685449
20201—437
20212—163
20222—059
20230—099
20241—059
20251—046
20260—0—

What is it indicated for?

The nContact Coagulation System is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K013392

11 other devices cite the same predicate.

  • K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical…Medtronic, Inc. · 2008
  • K073605Atricure Coolrail Linear PenAtriCure, Inc. · 2008
  • K043579Atricure Bipolar SystemAtriCure, Inc. · 2007
  • K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular · 2007
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 20061 recall
  • K050459Atricure Isolator Transpolar PenAtriCure, Inc. · 20051 recall

More from Ncontact Surgical, Inc.

7 FDA decisions under this applicant name. See the company

  • K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 20141 recall
  • K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
  • K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc. · 2009
  • K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc. · 2008
  • K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc. · 2007

Recent decisions in OCL

The OCL category page

  • K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025
  • K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024
  • K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator®…AtriCure, Inc. · 2022
  • K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc. · 2022
  • K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021

https://510kreport.com/device/K063012 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063012: Ncontact Coagulation System Kit, Model CSK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063012

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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