NUMERIS COAGULATION SYSTEM WITH VISITRAX - Numeris Coagulation System With Visitrax, Model(S) Csk-021

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K082203 ↗

FDA Product Code

OCL

Models / Variants

Numeris Coagulation System With Visitrax, Model(S) Csk-021

CSK-022

Csk-023

Csk-025

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Numeris Guided Coagulation System with Visitrax, Models Csk-121, -122, -123 and -125

  Class II

  FDA 510(k) K090202 Active Cleared 17 Feb 2009

• Ncontact Coagulation System Kit, Model Csk

  Class II

  FDA 510(k) K063012 Active Cleared 1 Dec 2006

• Epi-Sense Guided Coagulation Device with Visitrax

  Class II

  FDA 510(k) K142084 Active Cleared 28 Oct 2014

• Ncontact Visitrax Guided Coagulation System Kit, Models Csk-212 and Csk-515

  Class II

  FDA 510(k) K071819 Active Cleared 26 Jul 2007

• Ncontact Coagulation System Kit

  Class II

  FDA 510(k) K062539 Active Cleared 1 Dec 2006

• Epi-Sense Guided Coagulation Device with Visitrax

  Class II

  FDA 510(k) K120857 Active Cleared 13 Nov 2012