510(k) K142084 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
| Applicant | Ncontact Surgical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Oct 28, 2014 |
| Received | Jul 31, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2019 | AtriCure, Inc. EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation Terminated |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.