# K063012: Ncontact Coagulation System Kit, Model CSK

- Pathway: 510(k) (Traditional)
- Applicant: Ncontact Surgical, Inc.
- Decided: Dec 1, 2006 after 60 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- 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 K921884 (1992). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002)
- K041599: Cobra Adhere Surgical System, Estech, Inc. (2004) Summary page 1.
- K053326: Estech Cobra Electrosurgical Unit & Cable, Endoscopic Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K082203: Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025 (2008), 4 descendants of its own
- K071819: Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515 (2007), 4 descendants of its own
- K090202: Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125 (2009), 3 descendants of its own
- K120857: Epi-Sense Guided Coagulation Device with Visitrax (2012), 2 descendants of its own
- K142084: Epi-Sense Guided Coagulation Device with Visitrax (2014), 1 descendant of its own

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

Source page: https://510kreport.com/device/K063012
Methodology: https://510kreport.com/methodology