# K082203: Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025

- Pathway: 510(k) (Special)
- Applicant: Ncontact Surgical, Inc.
- Decided: Dec 30, 2008 after 147 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: 5 generations back to K921884 (1992). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063012: Ncontact Coagulation System Kit, Model CSK, Ncontact Surgical, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K193162: EPi-Sense Guided Coagulation System with VisiTrax (2019), 0 descendants of its own

## Indications for use
The NumerisTM Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.

Source page: https://510kreport.com/device/K082203
Methodology: https://510kreport.com/methodology