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510(k) K193162

EPi-Sense Guided Coagulation System with VisiTrax by AtriCure, Inc. — Product Code OCL

K193162 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "EPi-Sense Guided Coagulation System with VisiTrax". The FDA issued a decision of Substantially Equivalent on December 13, 2019. 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. AtriCure, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
November 15, 2019
Clearance Type
Special
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 AtriCure, Inc.

  • K252056 — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (July 24, 2025)
  • K250371 — cryoICE cryoXT cryoablation probe (cryoXT) (April 10, 2025)
  • K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) (January 15, 2025)
  • K243157 — AtriCure cryoICE BOX (ACM) (October 29, 2024)
  • K234151 — Isolator Synergy EnCapture Ablation System (EMH) (August 27, 2024)
  • K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM) (July 29, 2024)
  • K233959 — EPi-Ease Epicardial Access Device (EAS) (February 13, 2024)
  • K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); Atri (November 2, 2023)
  • K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablatio (October 26, 2023)
  • K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® L (December 30, 2022)

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)
  • K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (November 4, 2019)
  • K191526 — Cardioblate CryoFlex Surgical Ablation System (October 1, 2019)
  • K190587 — Coolrail Linear Pen (July 24, 2019)

FDA data resources