510(k) Report

FDA applicant

Ncontact Surgical, Inc.

Morrisville, NC7 decisions2006–20141 recall

FDA records 7 decisions for Ncontact Surgical, Inc. (Morrisville, NC) from 2006 to 2014: 7 510(k) clearances. Most are in product codes OCL (Surgical Device, For Cutting, Coagulation…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 14 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Ncontact Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

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

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ncontact Surgical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ncontact Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac…6decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 20062cite it
  • K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc. · 20091cites it
  • K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc. · 20071cites it
  • K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 20121cites it
  • K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc. · 20081cites it
  • K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 20141cites it

What has FDA decided for it lately?

  • 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
  • K062539Ncontact Coagulation System KitNcontact Surgical, Inc. · 2006
  • K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006

All 7 as Ncontact Surgical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142084EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage…May 29, 2019Class II