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510(k) K120857

EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX by Ncontact Surgical, Inc. — Product Code OCL

K120857 is an FDA 510(k) premarket notification submitted by Ncontact Surgical, Inc. for the device "EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX". The FDA issued a decision of Substantially Equivalent on November 13, 2012. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Ncontact Surgical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2012
Date Received
March 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Other clearances by Ncontact Surgical, Inc.

  • K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (October 28, 2014)
  • K090202 — NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND (February 17, 2009)
  • K082203 — NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK (December 30, 2008)
  • K071819 — NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 (July 26, 2007)
  • K063012 — NCONTACT COAGULATION SYSTEM KIT, MODEL CSK (December 1, 2006)
  • K062539 — NCONTACT COAGULATION SYSTEM KIT (December 1, 2006)

Other clearances for product code OCL

  • K252056 — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (July 24, 2025)
  • K234151 — Isolator Synergy EnCapture Ablation System (EMH) (August 27, 2024)
  • K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® L (December 30, 2022)
  • K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 (December 22, 2022)
  • K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (July 26, 2021)
  • K211311 — AtriCure Isolator® Synergy™ Surgical Ablation System (May 28, 2021)
  • K200514 — Cardioblate Gemini-s Surgical Ablation Device (June 3, 2020)
  • K193162 — EPi-Sense Guided Coagulation System with VisiTrax (December 13, 2019)
  • K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (November 4, 2019)
  • K191526 — Cardioblate CryoFlex Surgical Ablation System (October 1, 2019)

FDA data resources